Prosthetic valve for avoiding obstruction of outflow

ABSTRACT

A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.

CROSS-REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 15/418,511, filed Jan. 27, 2017, which application claimspriority to U.S. Provisional Patent Application No. 62/288,987, filedJan. 29, 2016.

The present application is related to: U.S. Pat. No. 8,579,964, filedApr. 28, 2011; US Patent Publication Number 2015/0216655, filed Apr. 13,2015; United State Patent Publication Number 2015/0257878, filed Apr.21, 2015; United States Patent Publication Number 2014/0039611, filedOct. 4, 2013; United States Patent Publication Number 2013/0211508,filed Nov. 16, 2012; United States Patent Publication Number2014/0052237, filed Feb. 8, 2013; United States Patent PublicationNumber 2014/0155990, filed May 5, 2013; United States Patent PublicationNumber 2014/0257467, filed Mar. 3, 2014; and United States PatentPublication Number 2014/0343669, filed Apr. 1, 2014; the entire contentswhich are incorporated herein by reference in their entireties for allpurposes.

BACKGROUND OF THE INVENTION

Mitral regurgitation, also known as mitral insufficiency or mitralincompetence, is a heart condition in which the mitral valve does notclose properly. This results in abnormal leakage of blood retrogradefrom the left ventricle through the mitral valve back upstream into theatrium. Persistent mitral regurgitation can result in congestive heartfailure. Traditional surgical repair of the valve generally results in agood clinical outcome but requires open heart surgery and a lengthy andcostly hospital stay with an extended recovery period. More recently,minimally invasive procedures have been developed to deliver aprosthetic heart valve percutaneously over a catheter through thepatient's vasculature to the heart. Alternatively, a transapicalprocedure is used to introduce the prosthesis through the chest wall andthrough the apex of the heart. An exemplary prosthesis includes thatdescribed in U.S. Pat. No. 8,579,964, the entire contents of which areincorporated herein by reference in their entirety for all purposes.These prostheses and delivery procedures appear to be promising, but incertain circumstances they may obstruct blood flow, cause blood flowthrough the prosthesis to be turbulent, or disrupt the natural flowpath, thereby potentially resulting in hemodynamic problems. Therefore,it would be desirable to provide improved devices, systems, and methodsthat avoid obstructing blood outflow and that maintain the natural flowpath and natural hemodynamics. At least some of these objectives may bemet by the exemplary embodiments described herein.

SUMMARY OF THE INVENTION

The present invention generally relates to medical systems, devices, andmethods, and more particularly relates to prosthetic heart valves thatmay be used to repair a valve such as a mitral valve, a heart valve, orany other valve.

In a first aspect, a prosthetic heart valve for implantation in a nativemitral valve of a patient comprises a radially expandable anchor framehaving an expanded configuration and a collapsed configuration. Theheart valve also comprises a prosthetic valve coupled to the anchorframe. The prosthetic valve comprises a plurality of prosthetic valveleaflets each having a free end and a fixed end, with the fixed endcoupled to the anchor frame, and the free ends of the plurality ofprosthetic valve leaflets have an open configuration and a closedconfiguration. In the open configuration, the free ends are disposedaway from one another to allow antegrade blood flow therethrough, and inthe closed configuration the free ends are disposed adjacent one anotherto substantially prevent retrograde blood flow therethrough. Theprosthetic mitral valve is configured to direct blood flow passingthrough the prosthetic valve in a non-turbulent manner and circulardirection along a posterior wall of the patient's left ventricle towardsthe apex of the heart and upward along a septal wall until it is ejectedout the left ventricular outflow tract during systole.

The blood flow substantially maintains momentum and conserves energy asit flows through the prosthetic mitral valve and left ventricle and outthe left ventricular outflow tract. The blood flow is indirectlydirected to the apex of the heart or the septal wall.

The plurality of prosthetic valve leaflets may comprise an anteriorprosthetic leaflet that is sized to span the entire width of the nativeanterior leaflet. In systole, the anterior prosthetic leaflet maydeflect away from the left ventricular outflow tract to provide a clearunobstructed outflow path for the blood flow.

In another aspect, a prosthetic heart valve for implantation in a nativemitral valve of a patient comprises a radially expandable anchor framehaving an expanded configuration and a collapsed configuration. Theprosthetic heart valve also comprises a prosthetic valve coupled to theanchor frame that comprises a plurality of prosthetic valve leafletseach having a free end and a fixed end. The fixed end is coupled to theanchor frame, and the free ends of the plurality of prosthetic valveleaflets have an open configuration and a closed configuration. In theopen configuration the free ends are disposed away from one another toallow antegrade blood flow therethrough, and in the closed configurationthe free ends are disposed adjacent one another to substantially preventretrograde blood flow therethrough. The plurality of prosthetic valveleaflets comprise an anterior prosthetic leaflet sized to span theentire width of the native anterior leaflet. In systole, the anteriorprosthetic leaflet deflects away from the left ventricular outflow tractto provide a clear unobstructed outflow path.

The prosthetic heart valve may be configured to direct blood flowthrough the prosthetic valve in a non-turbulent manner and blood flow ispreferably directed in a circular direction along a posterior wall ofthe patient's s left ventricle towards the apex of the heart and upwardalong a septal wall until it is ejected out the left ventricular outflowtract. The blood flow preferably substantially maintains momentum andconserves energy as it flows through the prosthetic heart valve and leftventricle and out the left ventricular outflow tract.

In any aspect, the anchor frame may comprise an anterior anchoring tabconfigured to anchor on a fibrous trigone of the native mitral valve oron any tissue anterior of the anterior native leaflet and adjacentthereto. The anchor frame may also comprise a second anterior anchoringtab that is configured to anchor on a second fibrous trigone of thenative mitral valve or any tissue anterior of the anterior nativeleaflet and adjacent thereto. The anchor frame may comprise a D-shapedcross-section having a substantially flat anterior portion and acylindrically shaped posterior portion. The flat anterior portionprevents impingement of the prosthetic heart valve on the leftventricular outflow tract, and the cylindrically shaped portion engagesthe posterior portion of the native mitral valve. The anchor frame mayalso comprise one or more commissure posts, and an anterior anchoringtab. The one or more commissure posts may have a free end and anopposite end coupled to the anchor frame. The plurality of commissureposts may be coupled to the plurality of prosthetic valve leaflets, andthe anterior anchoring tab may be configured to anchor on a fibroustrigone of the native mitral valve or on any tissue anterior of theanterior native valve leaflet and adjacent thereto. The anterioranchoring tab and the one or more commissure posts may be nested in oneanother when the anchor frame is in the collapsed configuration. Theanterior anchoring tab may originate from a circumferential position onthe anchor frame, and the one or more commissure posts also mayoriginate from the same circumferential position on the anchor frame asthe anterior anchoring tab. The anterior anchoring tab may originatefrom the one or more commissure posts, or the one or more commissureposts may originate from the anchoring tab.

In another aspect, a method of treating a native mitral valve in apatient's heart comprises providing a prosthetic mitral valve, anchoringthe prosthetic mitral valve in the native mitral valve, and directingblood flow in a non-turbulent manner. The blood flow is directed throughthe prosthetic mitral valve in a circular direction along a posteriorwall of the patient's left ventricle towards the apex of the heart andupward along a septal wall until it is ejected out the left ventricularoutflow tract.

The method may further comprise substantially maintaining momentum ofthe blood flow and conserving energy as the blood flows through theprosthetic mitral valve and left ventricle and out the left ventricularoutflow tract. Directing the blood flow may comprise indirectlydirecting the blood flow to the apex of the heart or the septal wall.The prosthetic mitral valve may comprise an anterior prosthetic leafletspanning the width of the native anterior valve leaflet, and the methodmay further comprise deflecting the anterior prosthetic leaflet awayfrom the left ventricular outflow tract to provide a clear unobstructedoutflow path during systole. Anchoring the prosthesis may compriseanchoring an anterior anchoring tab disposed on an anterior portion ofthe prosthetic valve to a fibrous trigone of the native mitral valve orto tissue anterior of the native anterior valve leaflet and adjacentthereto.

In yet another aspect, a method of treating a native mitral valve in apatient's heart comprises providing a prosthetic mitral valve having ananterior prosthetic leaflet that spans the width of the native anteriorvalve leaflet, anchoring the prosthetic mitral valve in the nativemitral valve, and deflecting the prosthetic anterior leaflet in systoleaway from the left ventricular outflow tract during systole therebycreating an unobstructed outflow path.

The method may further comprise directing blood flow in a non-turbulentmanner through the prosthetic mitral valve and in a circular directionalong a posterior wall of the patient's left ventricle towards the apexof the heart and upward along a septal wall until it is ejected out theleft ventricular outflow tract. Anchoring the prosthesis may compriseanchoring an anterior anchoring tab disposed on an anterior portion ofthe prosthetic valve to a fibrous trigone of the native mitral valve orto tissue anterior of the native anterior leaflet and adjacent thereto.

In another aspect, a prosthetic heart valve for implantation in a nativemitral valve of a patient comprises a radially expandable anchor framehaving an expanded configuration and a collapsed configuration; and aprosthetic valve coupled to the anchor frame. The prosthetic valvecomprises a plurality of prosthetic valve leaflets each having a freeend and a fixed end. The fixed end is coupled to the anchor frame andthe free ends of the plurality of prosthetic valve leaflets have an openconfiguration and a closed configuration. In the open configuration thefree ends are disposed away from one another to allow antegrade bloodflow therethrough, and in the closed configuration the free ends aredisposed adjacent one another to substantially prevent retrograde bloodflow therethrough. The plurality of prosthetic valve leaflets comprisean anterior prosthetic leaflet sized to span the entire width of thenative anterior leaflet. In systole, the anterior prosthetic leafletdeflects away from the left ventricular outflow tract to provide a clearunobstructed outflow path.

The anchor frame may comprise an anterior anchoring tab configured toanchor on an anterior portion of the native mitral valve and theanterior portion of the native mitral valve may comprise a fibroustrigone. The anchor frame may comprise a second anterior anchoring tabconfigured to anchor on a second anterior portion of the native mitralvalve. In some embodiments, the anchor frame can comprise a D-shapedcross-section having a substantially flat anterior portion and acylindrically shaped posterior portion, wherein the flat anteriorportion prevents impingement of the prosthetic heart valve on the leftventricular outflow tract, and the cylindrically shaped posteriorportion engages a posterior portion of the native mitral valve. In someexamples, the anchor frame can comprise one or more commissure posts,and an anterior anchoring tab, the one or more commissure posts having afree end and an opposite end coupled to the anchor frame, the one ormore commissure posts coupled to the plurality of prosthetic valveleaflets.

The anterior anchoring tab can be configured to anchor on an anteriorportion of the native mitral valve. In some embodiments, the anterioranchoring tab and the one or more commissure posts can be nested in oneanother when the anchor frame is in the collapsed configuration. Theanterior anchoring tab originates from a circumferential position on acircumference of the anchor frame, and wherein the one or morecommissure posts also originate from the same circumferential positionon the circumference of the anchor frame as the anterior anchoring tab.The anterior anchoring tab can originate from the one or more commissureposts, or the one or more commissure posts can originate from theanterior anchoring tab.

In some examples, the anchor frame can further comprise a plurality ofchordal bumper struts originating from the one or more commissure posts.The plurality of chordal bumper struts can be configured to disposenative sub-valvular anatomy away from the LVOT. In some embodiments, thecommissure posts can comprise an anchoring element adjacent a free endof the commissure post, the anchoring element configured to engage adelivery system. The anchor frame can further comprise a plurality ofwishbone shaped struts originating from the one or more commissureposts. The plurality of wishbone shaped struts can be configured toarcuately span the distance between adjacent commissure posts. Eachwishbone shaped strut can be comprised of an anchoring element disposedat an apex of the wishbone shaped strut or adjacent a free end of thewishbone shaped strut. The anchoring element can be configured to engagea delivery catheter. The plurality of wishbone shaped struts can bedeformable members and can allow radial compression of the anchor frameupon retraction into the delivery catheter. The anchoring element cancomprise a single threaded connector, a plurality of threadedconnectors, a buckle connector, or a prong connector.

In another aspect, a prosthetic heart valve for implantation in a nativemitral valve of a patient comprises a radially expandable anchor frame,an anterior anchoring tab coupled to the anchor frame, and a prostheticvalve coupled to the anchor frame. The radially expandable anchor framehas an expanded configuration and a collapsed configuration and anupstream end and a downstream end. The radially expandable anchor framecomprises one or more commissure posts having a free end and an oppositeend coupled to the anchor frame adjacent the downstream end, and ananterior anchoring tab coupled to the anchor frame adjacent thedownstream end. The anterior anchoring tab is configured to anchor on ananterior portion of the native mitral valve. The anterior anchoring taband the one or more commissure posts are nested in one another when theanchor frame is in the collapsed configuration. The prosthetic valvecomprises one or more prosthetic valve leaflets each having a free endand a fixed end, wherein the fixed end is coupled to the anchor frame.The one or more commissure posts are coupled to the one or moreprosthetic valve leaflets.

In some embodiments, the free ends of the one or more prosthetic valveleaflets can have an open configuration and a closed configuration. Inthe open configuration the free ends can be disposed away from oneanother to allow antegrade blood flow therethrough, and in the closedconfiguration the free ends can be disposed adjacent one another tosubstantially prevent retrograde blood flow therethrough. The one ormore prosthetic valve leaflets can comprise an anterior prostheticleaflet sized to span a width of a native anterior valve leaflet betweentwo native fibrous trigones. In systole, the anterior prosthetic leafletcan deflect away from the left ventricular outflow tract to provide aclear unobstructed outflow path. The anterior portion of the nativemitral valve can comprise a fibrous trigone.

In some examples, the anchor frame can comprise a second anterioranchoring tab configured to anchor on a second anterior portion of thenative mitral valve. Additionally or in the alternative, the anchorframe can comprise a D-shaped cross-section having a substantially flatanterior portion and a cylindrically shaped posterior portion. The flatanterior portion can prevent impingement of the prosthetic heart valveon the left ventricular outflow tract, and the cylindrically shapedportion can engage the posterior portion of the native mitral valve.

The anterior anchoring tab can originate from a circumferential positionon a circumference of the anchor frame and the one or more commissureposts can also originate from the same circumferential position on thecircumference of the anchor frame as the anterior anchoring tab. In someexamples, the anterior anchoring tab can originate from the one or morecommissure posts, or the one or more commissure posts can originate fromthe anterior anchoring tab.

In another aspect, a method of treating a native mitral valve in apatient's heart comprises: providing a prosthetic mitral valve having ananterior prosthetic leaflet that spans a width of a native anteriorvalve leaflet; anchoring the prosthetic mitral valve in the nativemitral valve; and deflecting the prosthetic anterior leaflet in systoleaway from the left ventricular outflow tract during systole therebycreating an unobstructed outflow path. Anchoring the prosthetic mitralvalve in the native mitral valve can comprise anchoring an anterioranchoring tab disposed on an anterior portion of the prosthetic valve toan anterior portion of the native mitral valve. In some examples, theanterior portion of the native mitral valve can comprise a fibroustrigone.

The method can comprise radially expanding the prosthetic mitral valvefrom a collapsed configuration to an expanded configuration, whereinradially expanding the prosthetic mitral valve can comprise expandingone or more anterior anchoring tabs away from nested positions withinone or more commissure posts. The method can comprise radially expandingthe prosthetic mitral valve from a collapsed configuration to anexpanded configuration, wherein radially expanding can compriseexpanding one or more posterior anchoring tabs away from nestedpositions within one or more commissure posts. In some examples,anchoring the prosthetic mitral valve can comprise actuating an actuatormechanism on a delivery system in a first direction, which can comprisemoving a sheath catheter away from the prosthetic mitral valve to removea constraint thereby allowing the prosthetic mitral valve to expand. Themethod can further comprise actuating the actuator mechanism in a seconddirection opposite the first direction, which can comprise moving asheath catheter toward the prosthetic mitral valve to provide aconstraint thereby forcing the prosthetic mitral valve to be compressed.In some examples, actuating the actuator mechanism in the firstdirection can comprise moving a bell catheter away from an anchoringcatheter to remove a constraint thereby allowing a commissure anchor tobe released. The commissure anchor can comprise an anchoring elementthat engages a frame of the prosthetic mitral valve to the deliverysystem. Actuating the actuator mechanism in the second direction cancomprise moving the bell catheter toward the anchoring catheter toprovide a constraint that captures or restrains the commissure anchor.Providing the constraint that captures or restrains the commissureanchor can comprise releasably sliding a retaining element over thecommissure anchor. Moreover, actuating the actuator mechanism cancomprise moving a sheath catheter over the anchoring catheter therebyapplying a constraint, which can comprise allowing a commissure anchorto be compressed. The commissure anchor can comprise a flexibleanchoring element that can engage the frame of the prosthetic mitralvalve to the delivery system.

In another aspect, a method of treating a native mitral valve in apatient's heart comprises: providing a prosthetic mitral valve coupledto a radially expandable anchor frame having an upstream end and adownstream end, expanding the radially expandable anchor frame from acollapsed configuration to an expanded configuration, anchoring theprosthetic mitral valve in the native mitral valve, wherein the anterioranchoring tab anchors on an anterior portion of the native mitral valve,and radially expanding the anterior anchoring tab away from a nestedposition within the one or more commissure posts. The radiallyexpandable anchor frame comprises one or more commissure posts having afree end and an opposite end coupled to the anchor frame adjacent thedownstream end, and an anterior anchoring tab coupled to the anchorframe adjacent the downstream end. The anterior portion of the nativemitral valve can comprise a fibrous trigone. In some examples, radiallyexpanding the anchor frame can comprise expanding the one or morecommissure posts away from a nested position within the anterioranchoring tab.

The prosthetic mitral valve can comprise an anterior prosthetic leafletand the method can comprise spanning a width of a native anterior valveleaflet between two native fibrous trigones, deflecting the anteriorprosthetic leaflet away from a left ventricular outflow tract, andcreating an unobstructed outflow path by the deflection of the anteriorprosthetic leaflet.

In another aspect, a delivery system for delivering a prosthesis to atarget treatment area comprises: an inner guidewire catheter having aproximal end, a distal end, and a lumen extending therebetween, thelumen sized to slidably receive a guidewire; a flexible dilating tipcoupled to the guidewire catheter, the dilating tip having a tapered andflexible self-dilating edge, a sheath catheter slidably disposed overthe inner guidewire catheter, the sheath catheter having a proximal endand a distal end; an actuator mechanism operably coupled to the proximalend of the sheath catheter. Actuation of the actuator mechanism in afirst direction moves the sheath catheter away from the dilator tipthereby removing a constraint from the prosthesis and allowing theprosthesis to expand. Moreover, actuation of the actuator mechanism in asecond direction opposite the first direction moves the sheath catheterinto engagement with the dilator tip thereby enclosing the prosthesistherein.

The system can comprise a stationary anchoring catheter fixedly disposedover the guidewire catheter, the anchoring catheter having an anchorelement adjacent a distal end of the anchor catheter and configured toengage the prosthesis. In some examples, a bell catheter can be slidablydisposed over the anchoring catheter. The bell catheter can have a bellelement disposed adjacent a distal end of the bell catheter and the bellelement can constrain the prosthesis into engagement with the anchorcatheter. The anchoring catheter can have a flexible prong type anchorelement adjacent the distal end of the anchor catheter, configured toengage the prosthesis. The sheath catheter can be slidably disposed overthe anchoring catheter. In particular, an advancement of the distal endof the sheath catheter can collapse the flexible prong type anchorelements into engagement with the prosthesis.

In some embodiments, a stationary bell catheter can be fixedly disposedover the anchoring catheter. The bell catheter can have a bell elementdisposed adjacent a distal end of the bell catheter, and the bellelement can disengage the prosthesis from the anchor catheter. In someembodiments, the system can comprise a bell catheter rotatably disposedover the guidewire catheter. The bell catheter can have an internallythreaded bell element disposed adjacent a distal end of the bellcatheter, and the threaded bell element can constrain the prosthesisinto engagement. A second actuator mechanism can be operably coupled toa proximal end of the bell catheter. Actuation of the second actuatormechanism in a first direction can couple the prosthesis to the bellcatheter, providing a constraint for the prosthesis, and actuation ofthe second actuator mechanism in a second direction opposite the firstdirection can de-couple the prosthesis from the bell catheter, removingthe constraint from the prosthesis. The system can comprise a rotatingtorque catheter rotatably disposed over the guidewire catheter. Thetorque catheter can have a driving gear element adjacent a distal end ofthe torque catheter and configured to transmit torque. A plurality ofrotating thread-connector catheters can be rotatably disposed adjacentthe torque catheter. The thread-connector catheters can each have adriven gear element adjacent a distal end of each thread connectorcatheter, and a threaded socket adjacent to the distal end of eachthread connector catheter. The driven gear elements can be sized toenmesh with the driving gear element and receive torque, and thethreaded sockets can be configured to constrain the prosthesis intoengagement. A second actuator mechanism can be operably coupled to aproximal end of the torque catheter. Actuation of the second actuatormechanism in a first direction can couple the prosthesis to thethread-connector catheters and actuation of the second actuatormechanism in a second direction opposite the first direction cande-couple the prosthesis from the thread-connector catheters.

In any of the aspects, the method may further comprise radiallyexpanding the prosthetic mitral valve from a collapsed configuration toan expanded configuration. Radially expanding the prosthesis maycomprise expanding an anterior anchoring tab away from a nestedconfiguration with a commissure post.

These and other embodiments are described in further detail in thefollowing description related to the appended drawing figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 depicts the anatomical heart in an anterior view.

FIG. 2 shows a cross-section of FIG. 1, and the interior anatomy of theheart, including the left ventricular outflow tract (LVOT) and aprosthetic mitral valve.

FIG. 3 depicts the anatomical heart in a posterior view.

FIG. 4 shows a cross-section of FIG. 3, and the interior anatomy of theheart, particularly, the space inferior to the mitral and aortic valves.

FIG. 5 illustrates an embodiment of a prosthetic mitral valve configuredto avoid LVOT obstruction.

FIG. 6 depicts an inflow view of a tri-leaflet prosthetic mitral valveconfigured to avoid LVOT obstruction.

FIG. 7 depicts an outflow view of a tri-leaflet prosthetic mitral valveconfigured to avoid LVOT obstruction.

FIG. 8A shows an outflow view of a mono-leaflet prosthetic mitral valve,in the style of a duck-bill valve.

FIG. 8B shows an outflow view of a bi-leaflet prosthetic mitral valve.

FIG. 8C depicts an outflow view of an anterior mono-leaflet prostheticmitral valve, in the open position.

FIG. 8D shows an outflow view of an anterior mono-leaflet prostheticmitral valve, in the closed position.

FIG. 8E shows an outflow view of a tri-leaflet prosthetic mitral valve,with a large anterior leaflet.

FIG. 8F shows an outflow view of a tetra-leaflet prosthetic mitralvalve.

FIG. 9 shows a frame flat-pattern of a prosthetic mitral valve frame.

FIG. 10 shows a frame flat-pattern of a prosthetic mitral valve frame,with chordal bumper struts.

FIG. 11 shows a frame flat-pattern of a prosthetic mitral valve frame,with chordal bumper struts and wishbone shaped struts.

FIG. 12 shows a frame flat-pattern of a prosthetic mitral valve frame,with wishbone shaped struts.

FIG. 13 illustrates an embodiment of a prosthetic mitral valve withwishbone shaped struts, and fashioned to avoid LVOT obstruction.

FIG. 14 illustrates an embodiment of a prosthetic mitral valve withwishbone shaped struts, anchored to a delivery system.

FIG. 15A shows an embodiment of a delivery system and wishbone shapedstrut anchoring variation, with a plurality of threaded connectors,connected.

FIG. 15B shows an embodiment of a delivery system and wishbone shapedstrut anchoring variation, with a plurality of threaded connectors,disconnected.

FIG. 16A shows an embodiment of a delivery system and wishbone shapedstrut anchoring variation, with a split-threaded connector, connected.

FIG. 16B shows an embodiment of a delivery system and wishbone shapedstrut anchoring variation, with a split-threaded connector,disconnected.

FIG. 17A shows an embodiment of a delivery system and wishbone shapedstrut anchoring method, with a flexing pin connector, connected.

FIG. 17B shows an embodiment of a delivery system and wishbone shapedstrut anchoring method, with a flexing pin connector, disconnected.

FIG. 18A shows an embodiment of a delivery system and wishbone shapedstrut anchoring method, with a flexible buckle connector, connected.

FIG. 18B shows an embodiment of a delivery system and wishbone shapedstrut anchoring method, with an internal view of a flexible buckleconnector, connected.

FIG. 18C shows an embodiment of a delivery system and wishbone shapedstrut anchoring method, with an internal view of a flexible buckleconnector, disconnected.

FIG. 19A shows an embodiment of a delivery system and wishbone shapedstrut anchoring method, with an internal view of an anchor shapedconnector, connected.

FIG. 19B shows an embodiment of a delivery system and wishbone shapedstrut anchoring method, with an anchor shaped connector, unconstrainedto allow disconnection.

FIG. 20A depicts an embodiment of a delivery system in a closedconfiguration, with a prosthetic mitral valve loaded internally.

FIG. 20B depicts an embodiment of a delivery system in a partiallyopened configuration, with a prosthetic mitral valve loaded internallyand being deployed.

FIG. 20C depicts an embodiment of a delivery system in a substantiallyopened configuration, with a prosthetic mitral valve loaded internallyand in mid deployment.

FIG. 20D depicts an embodiment of a delivery system in a substantiallyopened configuration, with a prosthetic mitral valve loaded and nearlyreleased.

FIG. 20E depicts an embodiment of a delivery system in a fully openedconfiguration, with a prosthetic mitral valve loaded internally, justprior to final deployment.

FIG. 20F depicts an embodiment of a prosthetic mitral valve, postrelease.

FIGS. 21A-C show an embodiment of a delivery system having a slottedanchor mechanism that may accommodate anchored wishbone shaped struts.

FIG. 22 shows an enlarged view of an embodiment of a delivery systemhaving a slotted anchor mechanism that may accommodate anchored wishboneshaped struts.

FIG. 23 shows an exploded view of a delivery system having a slottedanchor mechanism that may accommodate anchored wishbone shaped struts.

FIGS. 24A-C show an embodiment of a delivery system having a flexibleconnector anchor mechanism that may accommodate pinned wishbone shapedstruts.

FIG. 25 depicts an exploded view of an embodiment of a delivery systemhaving a flexible connector anchor mechanism that may accommodate pinnedwishbone shaped struts.

FIG. 26A depicts an exploded view of an embodiment of a delivery systemhaving a sliding connector anchor mechanism that may accommodateflexible buckle wishbone shaped struts.

FIG. 26B depicts an enlarged view of an embodiment of a delivery systemhaving a sliding connector anchor mechanism that may accommodateflexible buckle wishbone shaped struts.

FIG. 27 depicts an exploded view of an embodiment of a delivery systemwith a singular screw connector anchor mechanism that may accommodatesplit-threaded wishbone shaped struts.

FIG. 28 shows an enlarged view of an embodiment of a delivery systemwith a singular screw connector anchor mechanism that may accommodatesplit-threaded wishbone shaped struts.

FIG. 29 shows an exploded view of an embodiment of a delivery systemwith a plurality of screw connector anchor mechanisms that mayaccommodate threaded wishbone shaped struts.

FIG. 30 shows an exploded view of the concentric catheters of anembodiment of a delivery system with a plurality of screw connectoranchor mechanisms that may accommodate threaded wishbone shaped struts.

FIG. 31 shows an enlarged view of the sun-gear and plurality of screwconnector anchor mechanisms at the end of an embodiment of a deliverysystem that may accommodate threaded wishbone shaped struts.

FIG. 32 shows turbulent blood flow in a heart.

FIG. 33 shows non-turbulent blood flow in a heart.

FIG. 34 illustrates a prosthetic mitral valve directing blood in theheart in a non-turbulent manner.

FIG. 35 illustrates a perspective view of a prosthetic valve.

FIG. 36A illustrates the atrial skirt of a prosthetic valve.

FIG. 36B illustrates a top view of a prosthetic valve.

FIG. 37 illustrates a flat pattern of a prosthetic valve.

FIG. 38 illustrates a perspective view of a prosthetic valve.

FIG. 39A illustrates an anterior view of a prosthetic valve.

FIG. 39B illustrates a top view of a prosthetic valve.

FIG. 40 illustrates deployment of a prosthetic valve.

FIG. 41 illustrates a side view of a prosthetic valve.

FIG. 42 illustrates a combined commissure post and anchor tab.

FIGS. 43A-43B illustrate an unexpanded and expanded anchor tab.

FIG. 43C illustrates a flat pattern for an expanded anchor tab.

FIG. 44 shows a D-shaped prosthesis.

FIG. 45 shows a side view of a prosthetic valve.

FIG. 46 shows a top view of a prosthetic valve with four leaflets andfour anchors.

FIG. 47 shows a top view of a prosthetic valve with three leaflets andthree anchors.

FIG. 48 shows a flat pattern of a prosthetic valve.

FIG. 49 shows native valve leaflets superimposed over anchor tabs.

FIG. 50 shows an inversion of the anchor tab with the commissure postnested within.

FIG. 51 shows an embodiment with two anchors located adjacent the nativeanterior leaflet and an expansion region void of similar anchors in theposterior portion.

FIG. 52 shows a flat pattern of a prosthetic valve.

FIG. 53 shows another flat pattern of a prosthetic valve.

FIG. 54 shows a perspective view of a prosthetic valve.

FIG. 55 shows a mitral valve adjacent the aortic valve.

FIG. 56 shows still another anchor tab nested in a commissure post inthe expanded configuration.

FIG. 57 shows an anchor tab nested in a commissure post in the expandedconfiguration.

FIG. 58 shows an anchor tab nested in a commissure post in the collapsedconfiguration.

FIG. 59 shows variable strut thickness.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the disclosed device, delivery system, andmethod will now be described with reference to the drawings. Nothing inthis detailed description is intended to imply that any particularcomponent, feature, or step is essential to the invention.

As used herein, like numbers refer to like elements.

FIG.1 provides an illustration of the anatomical heart, hereinrepresented by an anterior aspect 10 of the heart. Anterior views ofvarious structures of the anatomical heart are also presented. Thesuperior vena cava 50, right atrium 40, and right ventricle 20 are shownon the (viewer's) left side of said anterior aspect 10, with superiorand inferior structures being separated by the right coronary artery120. A cross-section line A-A divides the cardiac anatomy into sidesections and is further discussed in FIG. 2. Moving to the (viewer's)right side of the heart, an anterior view of the aorta 60 can be seen ina superior position to the pulmonary trunk 90. Beneath the pulmonarytrunk 90 are the left atrium 70 and left atrial appendage 80. Beneathand flanking to the (viewer's) left and right of the left atrialappendage 80 are the left anterior descending coronary artery 100 andthe intermediate coronary artery 110, respectively. Finally, inferior toall previously mentioned elements is the left ventricle 30.

FIG. 2 shows the internal structures of the heart after sectioning theanterior aspect 10 (as shown in FIG. 1) of the heart along cross-sectionA-A. The cross-section A-A is bounded by a hatched zone 130 thatrepresents the plane of sectioning. Beginning at the superior-mostelement, the aorta 140 is depicted in a posterior aspect. Below andbehind the aorta 140 is the right atrium 180. An interior view of theleft atrium 150 is shown, revealing where a prosthetic mitral valve 210may be located after implantation. The inflow region 220 of theprosthetic mitral valve 210 and the outflow region 230 of the prostheticmitral valve can also be seen. An anterior aspect 170 of the prostheticmitral valve 210 may be adjacent to a zone 190 of the left ventricularoutflow tract 200 (LVOT). An anterior anchoring tab 240 may be locatedin a position that avoids blockage of the LVOT 200. As systole occurs,and blood is shunted towards the LVOT 200 from beneath the prostheticmitral valve 210, there may be a capacious channel leading directly tothe aorta 140, due to the large area of the zone 190. This configurationmay leave the LVOT 200 free of obstruction from extraneous prosthesisbulkage or projections.

The prosthetic mitral valve may comprise one or more tabs. Theprosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, ormore than 10 tabs. A posterior anchoring tab 250 may be located oppositethe anterior anchoring tab 240 of the prosthetic mitral valve 210. Theposterior anchoring tab 250 may abut the native anatomy and rest againsta posterior ventricular shelf region 160, which is formed within theventricle at the junction of the ventricle and posterior mitral annulus(see FIG. 4 for a clearer depiction). A third anchoring tab is hidden isthe depiction of FIG. 2. A valve leaflet 260, typically constructed fromchemically-preserved pericardial tissue harvested from various speciessuch as bovine, porcine, or ovine species, may be located between theanterior anchoring tab 240 and the posterior anchoring tab 250. Furtherdetails relating to the prosthetic mitral valve 210 are providedbeginning with FIG. 5.

FIG. 3 provides an illustration of the anatomical heart, hereinrepresented by a posterior aspect 265 of the heart. Posterior views ofvarious structures of the anatomical heart are also presented. Beginningwith the most superior elements, a posterior aspect of the superior venacava 380 is adjacent to a posterior aspect of the aorta 370 and above aposterior aspect of the pulmonary trunk 390. Further depictedposteriorly are the right atrium 270, the left atrial appendage 280(appearing to the viewer's left), the left atrium 340, the rightpulmonary veins 350, and the left pulmonary veins 360 (appearing to theviewer's right). A cross-section line B-B divides the presented cardiacanatomy into superior and inferior sections and is further discussed inFIG. 4. The coronary arteries and relevant branches include the leftmarginal branch 290, the circumflex branch 300, the posterior leftventricular branch 310 of the left coronary artery, and the posteriorinterventricular branch 320 of the right coronary artery. Finally, inthe most inferior position of the elements is the apex of the heart 330.

FIG. 4 shows the internal structures of the heart after sectioning theposterior aspect 265 (as shown in FIG. 3) of the heart alongcross-section B-B. The cross-section B-B is bounded by a hatched zone400 that represents the plane of sectioning. Beginning at the top of thefigure, the posterior ventricular shelf 470 is adjacent to and connectedby tissue with the fixed end of the posterior mitral leaflet 450. Thisshelf may provide a location for a posterior anchoring tab of aprosthetic mitral valve, as described herein. An arcade of posteriorchordae tendinae 455 are located adjacent to and connected by tissuewith the posterior mitral leaflet 450, finding their insertion pointsalong the free edge of the leaflet. The fixed ends of the chordae 455find insertion points in both the antero-lateral papillary muscles 430and postero-medial papillary muscles 440. The papillary muscles 430 and440 act as muscular support bases for the tethering effect provided bysaid chordae, spanning the distance between leaflet free edge insertionand papillary muscle insertion while under dynamic tension. Directlyopposing the posterior mitral leaflet 450 is an anterior mitral leaflet460. During systole, the posterior mitral leaflet 450 and the anteriormitral leaflet 460 are brought into communication as their free edgesshut against each other, in order to prevent retrograde blood flow intothe left atrium. The free edge of the anterior leaflet 460 is alsoadjacent to and connected by tissue with an arcade of anterior chordaetendinae 465, which also find fixed end insertion points in both theantero-lateral 430 and postero-medial 440 papillary muscles, mirroringthe chordal structure of the posterior leaflet.

The fixed end of the anterior leaflet 460 is directly adjacent andconnected by tissue with the inflow of the aortic valve 500. Thisadjacency is commonly known as the aorto-mitral continuity. It is inthis region that a risk for outflow tract obstruction presents itself,necessitating the present invention, which aims to minimize LVOTobstruction. Flanking the fixed end of the anterior leaflet 460 areregions of dense cartilaginous tissue known as the fibrous trigones,which act as skeletal-like structures for the heart-at-large. Theantero-septal fibrous trigone 480 and the antero-lateral fibrous trigone490 are represented by triangles, which demarcate landing zones on whichthe anterior anchoring tabs of the prosthetic mitral valve (not shown)may abut during valve deployment. For reference, the tricuspid valve 410and the aorta 420 are shown at the bottom of the figure.

FIG. 5 illustrates the present invention in perspective, showing aprosthetic mitral valve 510 (210, as shown in FIG.2) with a largeanterior leaflet. The prosthesis may comprise an atrial region, anannular region, a valvular region, and an anchoring region. A frame 525may provide the structural means on which the entirety of the prostheticvalve may be erected, and is shown by dashed lines in FIG. 5. The framemay be a nitinol frame. The frame 525 may be layered within variousbiocompatible fabrics that provide excellent sealing properties. Thebiocompatible fabrics may comprise polyester, nylon, or any otherbiocompatible fabric as is known to one having skill in the art. Medicalgrade suture may used to sew the various fabrics onto the frame 525 toconstruct the prosthesis. The atrial region of the prosthesis maycomprise an atrial skirt 520 which acts as a flange and allows theinflow region of the valve (220, as shown in FIG. 2) to register andseal against the native mitral annulus, upon the floor of the leftatrium. The atrial skirt 520 may traverse the entire circumference ofthe inflow region (220, as shown in FIG. 2) of the prosthetic valve, andmay be in communication with and connected to an annular region 530 thatalso traverses the circumference of the prosthetic valve. In thisrepresentation, the anterior surface of the prosthetic valve is shownfacing away and to the right, from the viewer. As such, an anteriorleaflet 580 is shown facing away and to the right. One or more valveleaflets may form the valvular region of the prosthesis. The leafletsmay comprise the anterior leaflet 580, a postero-septal leaflet 570, anda postero-lateral leaflet 590. The anterior leaflet 580 may comprise ananterior leaflet inflow surface, as described herein. The postero-septalleaflet 570 may comprise a postero-septal leaflet inflow surface, asdescribed herein. The postero-lateral leaflet 590 may comprise apostero-lateral leaflet inflow surface, as described herein.

One or more of the plurality of leaflets may comprisechemically-preserved pericardial tissue. The chemically-preservedpericardial tissue may be treated with chemical preservatives thatpromote polymer cross-linking, render the tissue inert and biocompatibleto humans, and/or prepare the tissue for further sterilizationtreatments. The leaflet tissue may be derived from bovine, porcine, orovine sources, but shall not be limited to the aforementioned species.In the closed configuration, the free ends of each of the anteriorleaflet 580, postero-septal leaflet 570, and postero-lateral leaflet 590may meet at a triple-point of leaflet coaptation 600. Conversely, thefixed end of each leaflet may be sutured to both the annular region ofthe valve, and to the next adjacent leaflet at a specific location thatprovides increased structural resilience, as described herein. AlthoughFIG. 5 shows three leaflets, the prosthetic mitral valve may compriseany number of leaflets. For instance, the prosthetic mitral valve maycomprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 leaflets.

Each leaflet may be successively joined to the next adjacent leaflet ata commissure attachment point, through a commissure suture pad. Thus,the prosthetic mitral valve may comprise one or more commissureattachment points and one or more commissure suture pads. Specifically,the postero-septal 570 and anterior 580 leaflets may be joined togetherand attached to an antero-septal commissure attachment point 550 throughan antero-septal commissure suture pad 560, the anterior 580 andpostero-lateral 590 leaflets may be joined together and attached to anantero-lateral commissure attachment point 625 through an antero-lateralcommissure suture pad 615, and the postero-lateral 590 andpostero-septal 570 leaflets may be joined together and attached to aposterior commissure attachment point 645 through a posterior commissuresuture pad 640. Although FIG. 5 shows three commissure attachment pointsand three commissure suture pads, the prosthetic mitral valve maycomprise any number of commissure attachment points. For instance, theprosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, ormore than 10 commissure attachment points and 1, 2, 3, 4, 5, 6, 7, 8, 9,10, or more than 10 commissure suture pads.

One or more commissure anchors may extend away from the valve and intofree space from each of the commissure attachment points. For instance,an antero-septal commissure anchor 555 may extend from the antero-septalcommissure attachment point 560, an antero-lateral commissure anchor 620may extend from the antero-lateral commissure attachment point 625, anda posterior commissure anchor 650 may extend from the posteriorcommissure attachment point 645. Each of the commissure anchors maycomprise the means through which the prosthesis may be anchored andconnected to an appropriate delivery system, as described herein. Theshape of each of the plurality of commissure anchors may generallyresemble the shape of an anchor or half-moon, but those skilled in theart will recognize that any shapes that allow the plurality ofcommissure anchors to be anchored effectively to a potential deliverysystem may be implied by this element. Although FIG. 5 shows threecommissure anchors, the prosthetic mitral valve may comprise any numberof commissure anchors. For instance, the prosthetic mitral valve maycomprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissureanchors.

Extending away from each of the commissure attachment points, in thisinstance towards the valve, are one or more of anchoring tabs. Eachanchoring tab may comprise a fixed end which is in communication with acommissure attachment point, and a free end which extends towards theatrial skirt and provides an anchoring means through which theprosthetic may attach itself to the native anatomy. Anterior anchoringtabs may generally rest against the native fibrous trigones of themitral valve, while posterior anchoring tabs may generally rest againstthe posterior ventricular shelf of the mitral valve. An antero-septaltrigonal anchoring tab 540 (240, as shown in FIG. 2) may be connected ata fixed end to the antero-septal commissure anchor point 560, and mayhave a free end 545 that is brought to rest against the antero-septalfibrous trigone (480, as shown in FIG. 4). An antero-lateral trigonalanchoring tab 610 (260, as shown in FIG. 2) may be connected at a fixedend to the antero-lateral commissure anchor point 625, and may have afree end (not shown in this view) that is brought to rest against theantero-lateral fibrous trigone (490, as shown in FIG. 4). Finally, aposterior anchoring tab 630 (250, as shown in FIG. 2) may be connectedat a fixed end to the posterior commissure anchor point 645, and mayhave a free end 635 that is brought to rest against the posterior shelf(470, as shown in FIG. 4). Although FIG. 5 shows three anchoring tabs,the prosthetic mitral valve may comprise any number of anchoring tabs.For instance, the prosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6,7, 8, 9, 10, or more than 10 anchoring tabs.

FIG. 6 illustrates an inflow view 660 of a prosthetic mitral valve (510,as shown in FIG. 5). The approximate “D” shape of the prosthetic mitralvalve may be fully appreciated by tracing a path from the anterioraspect 690 of the valve inflow (flat side of the D shape) in a clockwisedirection until the posterior aspect 700 of the valve inflow(curvedportion of the D shape) is reached, and then back again to the anterioraspect 690 of the valve inflow. Adjacent the anterior aspect 690 of thevalve inflow is the anterior portion 670 of the atrial skirt (520, asshown in FIG. 5). Adjacent the posterior aspect 700 of the valve inflowis the posterior portion 680 of the atrial skirt. A plurality of framestruts 740 may encircle the valve inflow circumferentially. The framestruts 740 may provide structural support and attachment means for boththe anterior 670 and posterior 680 portions of the atrial skirt to theannular region of the prosthetic mitral valve (530, as shown in FIG. 5).The postero-lateral leaflet inflow surface 710 (corresponding to thepostero-lateral leaflet 590, as shown in FIG. 5), anterior leafletinflow surface 720 (corresponding to the anterior leaflet 580, as shownin FIG. 5), and postero-septal leaflet inflow surface 730 (correspondingto the postero-septal leaflet 570, as shown in FIG. 5) are alsodepicted. Also show are the posterior anchoring tab free end 635,antero-lateral trigonal anchoring tab free end 610, and antero-septaltrigonal anchoring tab free end 545.

FIG. 7 illustrates an outflow view 750 of a prosthetic mitral valve(510, as shown in FIG. 5). The triple-point of leaflet coaptation (600,as shown in FIG. 5) as previously mentioned, may be formed duringsystole, when a coaptation surface 775 of a postero-septal leaflet 770(570, as shown in FIG. 5), a coaptation surface 765 of a postero-lateralleaflet 760 (590, as shown in FIG. 5), and a coaptation surface 785 ofan anterior leaflet 780 (580, as shown in FIG. 5) are brought intocontact with one another through valve closure. The previously describedcommissures and anchoring tabs are also depicted in this outflow view750, and are identified by a posterior anchoring tab 800 (630, as shownin FIG. 5) and associated posterior commissure anchor 805 (650, as shownin FIG. 5), an antero-septal trigonal anchoring tab 810 (540, as shownin FIG. 5) and associated antero-septal commissure anchor 815 (555, asshown in FIG. 5), and an antero-lateral trigonal anchoring tab 790 (610,as shown in FIG. 5) and associated antero-lateral commissure anchor 795(620, as shown in FIG. 5).

FIG. 8A illustrates an embodiment of a prosthetic mitral valve (510, asshown in FIG. 5) having a single mono-leaflet 830 that is in the styleof a duckbill valve, and is presented in an outflow view 820. Theduckbill style valve may be created by making an incision 840 atapproximately the center of the single mono-leaflet 830, which maycreate a leaflet coaptation edge on which the resultant valve mayfunction. The prosthetic mitral valve may further comprise one or moreof the anterior aspect 690 of the valve inflow, posterior aspect 700 ofthe valve inflow, the antero-lateral trigonal anchoring tab 790 andassociated antero-lateral commissure anchor 795, the posterior anchoringtab 800 and associated posterior commissure anchor 805, or theantero-septal trigonal anchoring tab 810 and associated antero-septalcommissure anchor 815.

FIG. 8B illustrates an embodiment of a prosthetic mitral valve (510, asshown in FIG. 5) comprising a dual or bi-leaflet configuration, againshown in an outflow view 850. The bi-leaflet configuration may berealized by way of a pair of leaflets, comprising an anterior leaflet870 and a posterior leaflet 860, which may be brought together duringsystole at a leaflet coaptation edge 880. The prosthetic mitral valvemay further comprise one or more of the anterior aspect 690 of the valveinflow, posterior aspect 700 of the valve inflow, the antero-lateraltrigonal anchoring tab 790 and associated antero-lateral commissureanchor 795, the posterior anchoring tab 800 and associated posteriorcommissure anchor 805, and/or the antero-septal trigonal anchoring tab810 and associated antero-septal commissure anchor 815.

FIGS. 8C and 8D show an embodiment of a mono-leaflet prosthetic mitralvalve (510, as shown in FIG. 5) seen from the outflow view 890comprising one large anterior leaflet 900 that may be able to span theentire valve orifice during systole, and seal against the posterioraspect of 700 of the valve inflow. In the open configuration, aposterior outflow region 910 may allow antegrade blood flow through thevalve and into the left ventricle, from the left atrium. The prostheticmitral valve may further comprise one or more of the anterior aspect 690of the valve inflow, posterior aspect 700 of the valve inflow, theantero-lateral trigonal anchoring tab 790 and associated antero-lateralcommissure anchor 795, the posterior anchoring tab 800 and associatedposterior commissure anchor 805, or the antero-septal trigonal anchoringtab 810 and associated antero-septal commissure anchor 815.

FIG. 8D shows that in the closed configuration 920, the large anteriorleaflet 900 has closed and that a posterior covering region 925 of saidanterior leaflet 900 has sealed against a leaflet coaptation edge 930that appears on the posterior aspect 700 of the valve inflow. Theprosthetic mitral valve may further comprise one or more of the anterioraspect 690 of the valve inflow, posterior aspect 700 of the valveinflow, the antero-lateral trigonal anchoring tab 790 and associatedantero-lateral commissure anchor 795, the posterior anchoring tab 800and associated posterior commissure anchor 805, or the antero-septaltrigonal anchoring tab 810 and associated antero-septal commissureanchor 815.

FIG. 8E illustrates an embodiment of a prosthetic mitral valve (510, asshown in FIG. 5) comprising a tri-leaflet configuration 940, and formedfrom the plurality of leaflets that are herein described as the largeanterior leaflet 960, the small postero-lateral leaflet 970, and thesmall postero-septal leaflet 950. During systole, said leaflets areforced to close and contact each other along a leaflet coaptation edge980. The prosthetic mitral valve may further comprise one or more of theanterior aspect 690 of the valve inflow, posterior aspect 700 of thevalve inflow, the antero-lateral trigonal anchoring tab 790 andassociated antero-lateral commissure anchor 795, the posterior anchoringtab 800 and associated posterior commissure anchor 805, or theantero-septal trigonal anchoring tab 810 and associated antero-septalcommissure anchor 815.

FIG. 8F depicts an embodiment of a prosthetic mitral valve (510, asshown in FIG. 5), seen from the outflow view and comprising atetra-leaflet configuration 990. The valve may be formed from theplurality of leaflets that are herein described as a posterior leaflet1000, a septal leaflet 1010, an anterior leaflet 1020, and a lateralleaflet 1030. During systole, the leaflets may be forced to close andcontact each other along a leaflet coaptation edge 1040. of theprosthetic mitral valve may comprise one or more anchoring tabs andcommissure anchors. Along with the antero-septal 810, and antero-lateraltrigonal anchoring tabs and corresponding commissure anchors (815antero-septal, and 795 antero-lateral), a postero-septal 1060 and apostero-lateral 1050 anchoring tab may be present, as well as thecorresponding postero-septal 1065 and postero-lateral 1055 commissureanchors. The prosthetic mitral valve may further comprise one or more ofthe anterior aspect 690 of the valve inflow, posterior aspect 700 of thevalve inflow, the antero-lateral trigonal anchoring tab 790 andassociated antero-lateral commissure anchor 795, the posterior anchoringtab 800 and associated posterior commissure anchor 805, or theantero-septal trigonal anchoring tab 810 and associated antero-septalcommissure anchor 815.

FIG. 9 depicts a frame flat pattern 1070, which is a representation of atoolpath that a machine-tool (such as a focused laser, router, end mill,or any other machine-tool as is known to one having skill in the art)may follow during the fashioning of a prosthetic valve (510, as shown inFIG. 5). The frame may be cut from a tubular stock of material. Forinstance, the frame may be cut from a tubular stock of nitinol. Thedevice may include several features discussed previously (introduced inFIG. 5), such as an antero-lateral commissure anchor 795 (element 620 ofFIG. 5), an antero-septal commissure anchor 815 (element 555 of FIG. 5),and a posterior commissure anchor 805 (element 650 of FIG. 5). Thephrase “strut format” refers to the elements illustrated in a frame flatpattern, whereupon the elements of the frame may be undeformed (i.e.,shapeset through metallurgical heat-treatments that are known to thoseskilled in the art) and generally resemble rectangular members or“struts.” Additional details regarding the commissure structures andtheir spatial relationships with the anchoring tabs are depicted in FIG.9. This flat pattern represents an embodiment of the prosthetic mitralvalve depicted in FIG. 5.

The prosthetic mitral valve may comprise one or more attachment rails,one or more commissures, one or more commissure attachment holes, one ormore commissure slots, and one or more commissure junctions. Theprosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, ormore than 10 attachment rails, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or morethan 10 commissures, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10commissure attachment holes, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than10 commissure slots, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10commissure junctions.

The antero-lateral commissure anchor 795 may protrude directly from theantero-lateral commissure 1085. The antero-lateral commissure may be theorigin and insertion of the antero-lateral anchoring tab 1110 (610, asshown in FIG. 5) via an antero-lateral commissural junction 1100. One ormore rows of antero-lateral commissure attachment holes 1090 may belocated adjacent to an antero-lateral commissure attachment slot 1095within the structure of the antero-lateral commissure 1085. Theattachment holes 1090 may provide a location for suture that may be usedto sew the antero-lateral commissure suture pads (615, as shown in FIG.5) into place. The antero-lateral commissure suture pads may work inconjunction with the antero-lateral commissure attachment holes to helpfasten the valve leaflets of the prosthetic mitral valve to the frame. Afree end 1111 of the antero-lateral anchoring tab 1110 is also shown, asare a free end 1116 of the antero-septal anchoring tab 1115 and a freeend 1121 of the posterior anchoring tab 1120. A plurality of struts orattachment rails may be used to locate and fasten leaflets onto theframe. Each strut may space a space between successive adjacentcommissures. Each strut may have a “u” or arc-shaped form. Specifically,an anterior leaflet attachment rail 1080 may span the space between theantero-lateral commissure 1085 and the antero-septal commissure 1086.The anterior leaflet attachment-rail 1080 may be used to attach theanterior leaflet (not shown) to the frame. A postero-septal leafletattachment rail 1130 may span the space between the antero-septalcommissure 1086 and the posterior commissure 1087. The postero-septalleaflet attachment rail 1130 may be used to attach the postero-septalleaflet (not shown) to the frame. The postero-lateral leaflet attachmentrail 1125 may span the space between the posterior commissure 1087 andthe antero-lateral commissure 1085. A postero-lateral leaflet attachmentrail 1125 may be used to attach the postero-lateral leaflet (not shown).The posterior commissure anchor 805, posterior commissure 1087,posterior anchoring tab 1120, and the free end 1121 of the posterioranchoring tab 1120 are shown on both sides of FIG. 9 to emphasize howthe prosthetic mitral valve may be laid out in a frame flatconfiguration.

Additional structures may support radial compression against the nativemitral annulus and/or help to seal the valve inflow against the leftatrial floor. A plurality of rows of annular rhomboids 1150 may belocated at the annular region 1140 of the frame, traversing thecircumference of the frame. A plurality of atrial skirt support struts1170 may emanate from the annular region 1140 and may act as supportbeams for a plurality of atrial skirt circumferential struts 1165. Theatrial skirt support struts may be substantially parallel to one anotherand may extend longitudinally. The atrial skirt circumferential strutsmay be substantially parallel to one another and may be substantially“v-shaped”. Each atrial skirt support struts may be connected at top andbottom to atrial skirt circumferential struts. The combination of atrialskirt support struts 1170 and atrial skirt circumferential struts 1165may form the atrial region 1160 of the valve frame and may provide alocation for the atrial skirt to be sutured onto the valve frame.

FIG. 10 illustrates an embodiment of a frame flat pattern 1180. Theframe flat configuration 1180 may comprise any or all of the elements ofFIG. 9, with further modifications. The frame flat configuration 1180may additionally comprise one or more strut features. The configurationmay comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 strutfeatures. For instance, one or more strut features may be added, eachadjacent to two of the leaflet attachment rails. A postero-lateralchordal bumper strut 1190 may run approximately parallel to thepostero-lateral leaflet attachment rail 1125. The postero-lateralchordal bumper strut 1190 may aid in valvular operation by pushing thenative chordae away from the prosthetic valve. This may further preventobstruction in the sub-valvular space and LVOT. The configuration maycomprise one or more bumper strut attachment points. The configurationmay comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 bumper strutattachment points. One or more postero-lateral chordal bumper strutattachment points 1195 may be located at each end of the postero-lateralchordal bumper strut 1190. Each postero-lateral chordal bumper strutattachment point 1195 may effectively connect an end of thepostero-lateral chordal bumper strut 1190 to the adjacent commissure. Apostero-septal chordal bumper strut 1210 may run approximately parallelto the postero-septal leaflet attachment rail 1130. One or morepostero-septal chordal bumper strut attachment points 1200 may belocated at each end of the postero-septal chordal bumper strut 1210.Each postero-septal chordal bumper strut attachment point 1200 mayeffectively connect and end of the postero-septal chordal bumper strut1210 to the adjacent commissure. The postero-septal chordal bumper strut1210 may be functionally equivalent to the postero-lateral chordalbumper strut 1190. The postero-septal choral bumper strut attachmentpoints 1200 may be functionally equivalent to the postero-lateral choralbumper strut attachment points 1195.

FIG. 11 shows an embodiment of a frame flat pattern 1220. The frame flatconfiguration 1220 may comprise any or all of the elements of FIG. 10,with further modifications. The frame flat configuration 1220 mayfurther comprise one or more wishbone-shaped members and an absence ofthe previously described commissure anchors. These alterations mayprovide an alternative method of anchoring the valve frame to a deliverysystem, as described herein. The configuration may comprise one or morewishbone struts, one or more wishbone anchors, and one or more wishboneattachment points. The configuration may comprise 1, 2, 3, 4, 5, 6, 7,8, 9, 10, or more than 10 wishbone struts, 1, 2, 3, 4, 5, 6, 7, 8, 9,10, or more than 10 wishbone anchors, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,or more than 10 wishbone attachment points. A postero-lateral wishboneshaped strut 1230 may emanate from a first strut attachment point 1240on the antero-lateral commissure 1085. The postero-lateral wishboneshaped strut 1230 may arc upwardly and across the postero-lateralleaflet space until it meets a second strut attachment point 1240located on the posterior commissure 1087. At the apex of thepostero-lateral wishbone shaped strut 1230 may be a postero-lateralwishbone anchor 1235 which may replace the previously depictedantero-lateral and posterior commissure anchors (795 and 805 of FIG. 10,respectively). The postero-lateral wishbone anchor 1235 may befunctionally and structurally equivalent to the antero-lateral andposterior commissure anchors. Additionally, a postero-septal wishboneshaped strut 1250 may emanate from a first strut attachment point 1260on the antero-septal commissure 1086. The postero-septal wishbone shapedstrut may arc upwardly and across the postero-septal leaflet space untilit meets a second strut attachment point 1260 located on the posteriorcommissure 1087. At the apex of the postero-septal wishbone shaped strut1250 may be a postero-septal wishbone anchor 1255 which may replace thepreviously depicted antero-septal and posterior commissure anchors (815and 805 of FIG. 10, respectively). The postero-septal wishbone anchormay be functionally and structurally equivalent to the antero-septal andposterior commissure anchors. The wishbone shaped struts may allow theprosthetic mitral valve to be forced into an easily compressibleconfiguration for delivery with a catheter, as described herein. Thismay result in a more easily retractable and/or repositionableprosthesis. wishbone shaped strut

FIG. 12 shows yet an embodiment of a frame flat pattern 1270. The frameflat configuration 1220 may comprise any or all of the elements of FIG.11, with further modification. The frame flat configuration 1270 maylack certain elements of FIG. 11. For instance, the postero-lateralchordal bumper struts (1190, as shown in FIG. 11) and/or postero-septalchordal bumper struts (1210, as shown in FIG. 11) may be excluded fromthe frame flat configuration 1270. Save for the absence of said bumperstruts, the frame flat configuration 1270 may be functionally equivalentto the frame flat configuration 1220 of FIG. 11. A perspective view ofthe prosthetic mitral valve of FIG. 12 can be seen in FIG. 13.

FIG. 13 shows a perspective view of the prosthetic mitral valve shown asthe frame flat configuration 1270 in FIG. 12. Any or all of the featuresand elements previously described in FIG. 5 may be present in theembodiment of FIG. 13. The embodiment of FIG. 13 may be functionally andstructurally equivalent to the embodiment of FIG. 5, save for theaddition of one or more wishbone shaped struts and one or more wishboneattachment regions. The embodiment of FIG. 13 may comprise 1, 2, 3, 4,5, 6, 7, 8, 9, 10, or more than 10 wishbone shaped struts and 1, 2, 3,4, 5, 6, 7, 8, 9, 10, or more than 10 wishbone attachment regions. 1330.A postero-septal wishbone shaped strut 1320 may find a first insertionwith the frame at an antero-septal tab wishbone attachment region 1300,which may be located adjacent to the antero-septal commissure. Thepostero-septal wishbone shaped strut 1320 may find a second insertionwith the frame at a posterior tab wishbone attachment region 1290, whichmay be located adjacent to the posterior commissure. A postero-septalwishbone anchor 1255 may be located at the apex of the wishbone,allowing for attachment to a delivery system, as described herein. Apostero-lateral wishbone shaped strut 1330 may find a first insertionwith the frame at an antero-lateral tab wishbone attachment region 1310,which may be located adjacent to the antero-lateral commissure. Thepostero-lateral wishbone shaped strut 1330 may find a second insertionwith the frame at a posterior tab wishbone attachment region 1290, whichmay be located adjacent to the posterior commissure. A postero-lateralwishbone anchor 1235 may be located at the apex of the wishbone,allowing for attachment to a delivery system, as described herein.

Prior minimally invasive procedures have been developed to deliver aprosthetic heart valve percutaneously over a delivery catheter throughthe patient's vasculature to the heart, or through the use of atransapical procedure to introduce the prosthesis through the chest walland through the apex of the heart (330 as shown in FIG. 3). An exemplaryprosthesis includes that described in U.S. Pat. No. 8,579,964, theentire contents of which are incorporated herein by reference in theirentirety for all purposes. Further embodiments of exemplary deliverycatheters and delivery systems are described and illustrated in thefollowing figures.

FIG. 14 shows the prosthetic mitral valve with wishbone attachment ofFIG. 13. The prosthetic mitral valve 1280 may comprise any or all of theelements of FIG. 13. The prosthetic mitral valve 1280 may be connectedto a delivery system 1340. The delivery system 1340 may comprise acompletely withdrawn delivery catheter 1350. It should be readilyapparent that the aforementioned postero-septal commissure anchor (1255,as shown in FIG. 13) and postero-lateral commissure anchor (1235, asshown in FIG. 13) are presently hidden by an anchoring sleeve member1360 in FIG. 14. The delivery system 1340 is shown in FIG. 14 asconnected to a non-specific anchoring mechanism. Embodiments of theanchoring mechanism are described in FIGS. 15-19, as communicated byenlarged detail element 1345.

FIGS. 15A-B show an embodiment of an anchoring method used to anchorcommissure anchors to a delivery system utilizing a plurality ofthreaded connectors. FIG. 15A shows a plurality of threaded connectors1370 in a connected configuration. In the connected configuration, afirst male threaded connector 1390 and a second male threaded connector1395 may be in threaded connection with a first female threadedconnector 1375 and a second female threaded connector 1380,respectively. The first and second male threaded connectors (1390 and1395, respectively) may each comprise a segment of male threads 1400appearing at a free end of a wishbone shaped strut 1410. The wishboneshaped strut may replace the plurality of commissure anchors (1255 and1235, as shown in FIG. 13). The male threads may be sized to fasten andmate to similarly threaded first and second segments of female thread1405. Arrows 1385 indicate rotation of each of the first and secondfemale threaded connectors (1375 and 1380, respectively). Upon rotationin the direction of the arrows 1385, the connectors may be in the statedepicted in FIG. 15B.

FIG. 15B shows a plurality of threaded connectors (1390 and 1395) in adisconnected configuration 1420. It should be apparent that in the statedepicted in FIG. 15B, the male threaded connectors may be completelydisconnected from the female threaded connectors. Upon disconnection, aprosthetic valve that was initially attached to a catheter deliverysystem through the wishbone connectors may be fully released from itsdelivery system. A further discussion of the internal mechanismsresponsible for the operation of this embodiment of a delivery systembegins with the description of FIG. 29.

FIGS. 16A-B show an embodiment of an anchoring method used to anchorcommissure anchors to a delivery system using a single split-threadedconnector. FIG. 16A shows a split-threaded connector 1430 in a connectedconfiguration. One or more male split-threaded connectors 1450 may be inthreaded connection with one or more female split-threaded connectors1440. Each male split-threaded connector 1450 may comprise a segment ofmale thread 1455 appearing at a free end of a wishbone shaped strut1460. The wishbone shaped strut may replace the plurality of commissureanchors (1255 and 1235, as shown in FIG. 13). The male threads may besized to fasten and mate to similar threaded segments of female thread1445 within the female threaded connector 1440. Arrows 1435 indicaterotation of the individual female threaded connector 1440. Uponrotation, the connectors may be in the state depicted in FIG. 16B.

FIG. 16B shows the split-threaded connector 1455 in a disconnectedconfiguration 1470. It should be apparent that in the state depicted inFIG. 16B, the male split-threaded connector may be completelydisconnected from the female threaded connector. Upon disconnection, aprosthetic valve that was initially attached to a catheter deliverysystem through the wishbone connectors may be fully released from itsdelivery system. A further discussion of the internal mechanismsresponsible for the operation of this embodiment of a delivery systembegins with the description of FIG. 27.

FIGS. 17A-B show an embodiment of an anchoring method used to anchorcommissure anchors to a delivery using a flexing pin-connector typeanchoring mechanism. FIG. 17A shows a flexing pin-connector typeanchoring mechanism 1480 in a connected configuration. One or moreflexible sleeves 1490 may be closed about a plurality of pinholeconnectors 1530. The flexible sleeves 1490 may comprise a plurality offlexible sleeve portions 1495 that may be able to snap open and shutwhen a translating sleeve 1500 is drawn over or off of them. Thismovement of the translating sleeve may effective encapsulating theflexible sleeve portions 1495. The flexible sleeve 1490 may comprise ashape-settable and/or super-elastic nitinol material, as is known tothose having skill in the art. Each flexible sleeve portion 1495 maycomprise a terminal point 1510, appearing at the free end of theflexible sleeve 1490. The terminal points may allow connection of theflexing pin-connector type anchoring mechanism 1480 to wishbone shapedstruts 1520.

FIG. 17B shows the flexing pin-connector type anchoring mechanism 1480in a disconnected configuration 1540. The internal surface of each ofthe terminal points 1510 may comprise a connector pin 1555 which may fitinto a complimentary hole for pin connection 1560. Each of the wishboneshaped struts 1520 of the prosthetic mitral valve may terminate in apinhole connector 1530. The pinhole connectors may replace the pluralityof commissure anchors (1255 and 1235, as shown in FIG. 13). Arrows 1550indicate rotation of each of the individual flexible sleeve portions1495. Upon rotation, the connector may be in the state depicted in FIG.17B. Arrow 1545 indicates translation of the translating sleeve 1500over the flexible sleeve portions 1495. It should be apparent that inthe state depicted in FIG. 17B, the connector pins 1555 may becompletely disconnected from the holes for pin connection 1560. Upondisconnection, a prosthetic valve that was initially attached to acatheter delivery system through the wishbone connectors may be fullyreleased from its delivery system. A further discussion of the internalmechanisms responsible for the operation of this embodiment of adelivery system begins with the description of FIG. 24A.

FIGS. 18A-C show an embodiment of an anchoring method used to anchorcommissure anchors to a delivery system using a plurality of flexiblebuckle type anchoring mechanisms is employed. FIG. 18A shows a pluralityof flexible buckle type connectors 1570 in a connected configuration. Aplurality of flexible buckles 1580 may be in captured connection with,restrained by, or disposed within an aperture 1575 that is sized toaccept and retain the flexible buckles 1580 utilizing opposing tensileforces. The aperture may be fashioned in the side of a translatingsleeve 1500. Each of the flexible buckles may be located adjacent to andprotruding from the end of a wishbone shaped strut 1520, which mayreplace the plurality of commissure anchors (1255 and 1235, as shown inFIG. 13). A sheath catheter 1350 may be concentrically positioned overthe top of the translating sleeve 1500. When the translating sleeve 1500is drawn against the sheath catheter 1350, the mechanism of action maybe achieved.

FIG. 18B depicts the hidden structure of the flexible buckles 1580, asthe translating sleeve 1500 blocks said structure from view in FIG. 18A.

FIG. 18C shows the flexible buckle type anchoring mechanisms in adisconnected configuration. When the translating sleeve 1500 is drawnagainst the sheath catheter 1350, the flexible buckles 1585 may beforced closed by the inner surface of the sheath catheter 1500, andreleased from constraint. It should be apparent that in the statedepicted in FIG. 18C, the flexible buckle type connectors may becompletely disconnected from their aperture 1575 and associatedtranslating sleeve 1500. Upon disconnection, a prosthetic valve that wasinitially attached to a catheter delivery system through wishboneconnections may be fully released from its delivery system. A furtherdiscussion of the internal mechanisms responsible for the operation ofthis embodiment of a delivery system begins with the description of FIG.26A.

FIGS. 19A-B show an embodiment of an anchoring method used to anchorcommissure anchors to a delivery system using a plurality of anchorshaped commissure anchors. FIG. 19A shows a plurality of anchor shapedcommissure anchors 1630, adjacent to and connected with the ends of aplurality of wishbone shaped struts 1410, in a connected configuration.The plurality of commissure anchors 1630 may rest within a complimentaryplurality of slots 1615. The slots may act to retain the anchors andresist tensile forces that may be developed during operation of thedelivery system. The slots 1615 may be fashioned on the anchoring end1610 of an anchoring catheter 1600. The plurality of commissure anchors1630 depicted in FIG. 19A-B may be identical to the plurality ofcommissure anchors (1255 and 1235, as shown in FIG. 13) in design,construction, and function.

FIG. 19B shows the commissure anchors 1640 in an unconstrainedconfiguration that may allow disconnection. Arrow 1620 indicatestranslation of an anchoring sleeve member 1360. Upon translation, thestate depicted in FIG. 19B may be realized. It should be apparent thatin the state depicted in FIG. 19B, the commissure anchors 1640 may beunconstrained and capable of being disconnected from the slots 1615 ofthe anchoring catheter 1600. Upon disconnection, a prosthetic valve thatwas initially attached to a catheter delivery system may be releasedfrom its delivery system. A further discussion of the internalmechanisms responsible for the operation of this embodiment of adelivery system begins with the description of FIG. 21A.

FIGS. 20A-20F depict the successive stages of unsheathing an embodimentof a delivery system and implanting a mitral valve prosthesis. Althoughthe resultant effects of the operation of said delivery system (such asthe release of a constrained prosthetic mitral valve) are discussed withreference to the relevant elements necessary for illustration, themechanical relationships of the various internal components necessaryfor the physical realization of the delivery system embodiments are notillustrated or discussed until further below, in FIGS. 21-31. Thedeployment process as depicted in FIGS. 20A-20F proceeds as follows. Asheath catheter which may constrain a compressed prosthetic valvecomprised of tissues, fabrics, sutures and a nitinol frame may beretracted from the valve while in place within the implantation zone.The physiological temperature of the blood in a patient's heart maycause the nitinol material to expand and conform to the space in whichit has been implanted. As the prosthesis expands, elements of theinvention that are responsible for anchoring to the native anatomy mayalso expand, allowing the prosthesis to remain in place in order tofunction as a one-way valve and support proper circulation of blood. Itshall be recognized that the relevant anatomy has been previouslyillustrated in FIGS. 1-4, but is not repeated in the following figures,leaving room to focus on the prosthesis and delivery system.

FIG. 20A depicts an embodiment of a fully loaded (sheathed and closed)delivery system 1700. The delivery system may comprise a prostheticmitral valve (shown in FIGS. 20B-20F) that has been compressed andinserted into a sheath catheter 1350 prior to implantation. A long,tapered and flexible self-dilating dilator tip 1710 may aid theinsertion of the delivery system within a small incision that isprepared in the prospective patient (not shown). The incision may bemade in the thorax and may lead directly into and through the apex ofthe heart. The widest end of the dilator tip 1710 may be terminated byan edge 1720 that may register against and fits concentrically within aleading edge 1725 that may appear on the distal end of the sheathcatheter 1350. A lumen 1715 may be formed at the distal-most portion ofthe dilator tip 1710, and may extend throughout the entirety of thecatheter to which the dilator tip 1710 is attached.

FIG. 20B depicts an embodiment 1730 of a loaded delivery system with theatrial skirt revealed, showing the sheath catheter 1350 previouslydescribed in FIG. 20A translated a slight distance away from the dilatortip 1710. Specifically, the leading edge 1725 of the sheath catheter1350 may be moved away from the edge 1720 of the dilator tip 1710, andmay thereby reveale a partially constrained atrial skirt 1750.

FIG. 20C depicts an embodiment 1760 of a loaded delivery system with theanterior trigonal anchoring tabs revealed, showing the sheath catheter1350 previously described in FIG. 20B translated away from the dilatortip 1710 to an even greater extent. Specifically, the leading edge 1725of the sheath catheter 1350 may be moved further away from the edge 1720of the dilator tip 1710, and may thereby reveal most of the structure ofthe encapsulated prosthetic mitral valve. An atrial skirt 1770 may nowbe approximately released, yet a still partially constrained annularregion 1775 may remain constricted by the sheath catheter 1350. Theconfiguration of FIG. 20C may remove a constraint that may allow theself-expansion of a portion of the prosthetic mitral valve. Adjacent toand directly beneath the constrained annular region 1775 may be aconstrained anterior leaflet 1780, which may remain substantiallycompressed. Protruding from beneath the leading edge 1725 of the sheathcatheter 1350 may be a plurality of trigonal anchoring tabs, such as anantero-lateral trigonal anchoring tab 790 (with an associated free end1790), and an antero-septal trigonal anchoring tab 540 (with anassociated free end 545).

FIG. 20D depicts an embodiment 1800 of a loaded delivery system with theanterior trigonal anchoring tabs fully open, showing the sheath catheter1350 previously described in FIG. 20C translated away from the dilatortip 1710 to an advanced extent. Specifically, the leading edge 1725 ofthe sheath catheter 1350 may be moved further away from the edge 1720 ofthe dilator tip 1710, and may thereby reveal all of the structure of theencapsulated prosthetic mitral valve, except for the commissureattachment (not shown). The atrial skirt 1770 may now be completelyunconstrained, as may an annular region 1810. Adjacent to and directlybeneath annular region 1810 may be a partially constrained anteriorleaflet 1825, which may be almost completely released. The anteriorleaflet 1825 may be operational and able to coapt against any otherleaflets present in this embodiment (not shown). The plurality oftrigonal anchoring tabs (antero-lateral trigonal anchoring tab 790 andassociated free end 1790, and antero-septal trigonal anchoring tab 540and associated free end 545) may be splayed open due to the interactionbetween the leading edge 1725 of the sheath catheter 1350 and thestill-constrained wishbone shaped struts 1820 to which the trigonalanchoring tabs may be directly connected. This opening effect may allowthe trigonal anchoring tabs to reach around the native anterior mitralleaflet (460, as shown in FIG. 4) and through the anterior chordae (465,as shown in FIG. 4) in order to abut against the trigones after release.Emanating from and concentrically nested within the sheath catheter 1350may be a guidewire catheter 1830, which may be directly connected to andprovide support for the dilator tip 1710.

FIG. 20E shows an embodiment 1840 of a loaded delivery system, justprior to final release, showing the sheath catheter 1350 previouslydescribed in FIG. 20D translated away from the dilator tip 1710 to anadvanced extent. Specifically, the leading edge 1725 of the sheathcatheter 1350 may be moved further away from the edge 1720 of thedilator tip 1710, and may thereby reveal all of the structure of theencapsulated prosthetic mitral valve, such as the fully deployedwishbone shaped struts 1880, which may be about to be released from thedelivery system. The antero-septal 1860 and antero-lateral 1870 trigonalanchoring tabs may be released from their constraint, and may now be intheir final position. The anterior leaflet 1850 may be completely freed,and may be in an operable state spanning the native anterior leaflet.

FIG. 20E depicts final deployment 1890 with the delivery system removed.The wishbone shaped struts 1900 and associated commissure anchors 1910may be entirely released and free from constraint by the deliverysystem. In this depiction, the prosthesis of the present invention maybe fully functional, and free to operate within the native anatomy.

A thorough discussion of several relevant delivery system embodimentswill now be presented, with reference to elements appearing in FIGS.21-31.

FIGS. 21A-23 depict an embodiment of a delivery system that correspondsto the description relating to FIGS. 19A-19B and that may be compatiblewith the prosthetic mitral valve embodiment described in FIG. 13.

FIG. 21A shows an embodiment of a fully open, extended-length deliverysystem 1920. The delivery system may comprise a delivery system handle1940. The delivery system handle may comprise a slender, graspablemember 1960 that may allow for the housing of various mechanicalcomponents, and may provide a location for a family of concentricallynested catheters. The delivery system handle 1940 may also provide anactuation mechanism, such as in the form of a rotatable (see arrow 1950indicating rotation) thumbwheel 1955. The thumbwheel may besubstantially cylindrical and may have internal threads (not shown) thattransform rotational torque applied by a user into linear force. Thelinear force may be used to translate certain catheters from the familyof concentrically nested catheters. The previously discussed sheathcatheter 1350 is again present and may be a substantially cylindricaltube with an inner lumen, extending from within the delivery systemhandle 1940 to a leading edge 1725 that may transit the distance betweenthe edge 1720 of a dilator tip 1710 positioned at the distal-mostextremity of the entire device and a set distance proximally away fromthe edge 1720 that may equate substantially to the constrained length ofa prosthetic valve (not shown). An anchoring sleeve member 1360 may beconcentrically nested within the sheath catheter 1350, which may itselfalso have an inner lumen that extends from within the delivery systemhandle 1940 up to and slightly beyond the tip of an anchoring catheter1930. The anchoring catheter 1930 may itself be cylindrical andconcentrically nested within the anchoring sleeve member 1360. Furtherdetail regarding the anchoring catheter 1930 is provided in FIG. 22. Theinnermost concentrically nested catheter is the guidewire catheter 1830,which may be connected to the dilator tip 1710. There may be an innerlumen extending through the entire length of the delivery system, whichmay be appropriately sized to receive and transmit a guidewire (notshown) that may be placed within it. An arrow 1925 depicting translationshows how the sheath catheter 1350 may be brought toward the dilator tip1710 as the thumbwheel 1955 is rotated.

FIG. 21B shows the device introduced in FIG. 21A in a configuration1970, with the sole differences being the position of the sheathcatheter 1350 and the position of the anchoring sleeve member 1360. Thesheath catheter may be translated even further toward the dilator tip1710 (as depicted by arrow 1975 indicating translation). The anchoringsleeve member 1360 may also be translated. By translating toward thedilator tip 1710, the anchoring sleeve member 1360 may effectively coverup the anchoring catheter 1930, FIG. 21A. This is the same mechanicalrelationship depicted in FIGS. 19A and 19B, although in the reverseorder.

FIG. 21C shows a closed delivery system 1980, wherein the thumbwheel1955 may be rotated to its full extent, and the sheath catheter 1350 maybe brought to close against the dilator tip 1710.

FIG. 22 shows the embodiment and configuration of the device asillustrated in FIG. 21A with additional detail in the form of anenlarged view 1985. Specifically, a stabilizer member 1990 may belocated between the inner surface of the sheath catheter 1350 and theouter surface of the anchoring sleeve member 1360. The stabilizer membermay take the form of a star shaped cylindrical prism. The stabilizermember may force concentricity between said catheters while stillallowing blood and/or saline to flow past. The slotted end of theanchoring catheter 1930 is also portrayed. It may be seen that theanchoring sleeve member 1360 may be positioned concentrically around andin slidable communication with the anchoring catheter 1930. Theguidewire catheter 1830 is again shown exiting the anchoring catheter1930.

FIG. 23 illustrates an exploded view of the exemplary device of FIGS.21A-22B. The device may comprise a delivery system handle A-side 2140that may be in mated connection with a delivery system handle B-side2145. The device may effectively provide a housing and location for thefamily of concentrically nested catheters seen to the left side of thehandle elements (and described in FIGS. 22-22), and the various elementsseen to the right side of the handle elements. The device may comprise aneedle hub 2130, which may be in mated connection with the proximal end2000 of the guidewire catheter 1830. The mated connection may be formedusing adhesives. The needle hub 2130 may act as a connecting port,through which a syringe (not shown) may be attached to the device andused to flush sterile saline through the innermost lumen to remove airprior to insertion into a patient. A cylindrical anchoring nut 2120 maybe in threaded connection with threads on the proximal end 2035 of theanchoring catheter 2010. The cylindrical anchoring nut may be locatedwithin the plurality of handle halves 2140 and 2145 so as to fasten theanchoring catheter 2010 to the delivery system. An inner lumen may runthe entirety of the length of the anchoring catheter 2010 and may allowfor the concentric nesting of the guidewire catheter 1830 within. Aspring 2110 may be mated to and press against a bell slider cap 2100,which may itself mated to a bell slider 2090. The spring 2110 mayprovide a bias force with which the bell slider 2090 may be moved when aleadscrew 2080 is brought out of contact with it. In other words, byrotating the thumbwheel 1955, the leadscrew 2080 may be translatedlinearly and may be brought into contact with the distal portion of thebell slider 2090, which may in turn be biased against the spring 2110.The bell slider 2090 may act as a carriage for the proximal end 2060 ofthe bell catheter 2040 (previously referred to as an anchoring sleevemember 1360) and may allow the distal end 2050 of said bell catheter2040 to be brought away from the distal end 2020 of the anchoringcatheter 2010, which may be the mechanism responsible for final valvecommissure release. The leadscrew 2080 may also be translated in anopposite direction by turning the thumbwheel 1955, in order to close thedelivery system and seal the valve inside. This may be achieved by wayof the leadscrew's 2080 connection to a leadscrew cap 2070, which mayitself be mated to the proximal end 2065 of the sheath catheter 1350.Thus, rotating the thumbwheel 1955 in a first direction may move theleadscrew 2080 towards the dilator tip 1710, and by extension may alsomove the sheath catheter 1350 towards said dilator tip 1710 in order toclose the device. Rotating the thumbwheel 1955 in a second oppositedirection may move the leadscrew 2080 towards the bell slider 2090 andby extension may move both the sheath catheter 1350 and the bellcatheter 2040 away from the dilator tip 1710 to open the device andrelease the prosthetic valve contained within. It should be understoodthat while both the sheath catheter 1350 and bell catheter 2040 may movesynchronously by way of thumbwheel 1955 rotation, there may be a delayin contact provided by the dimensions of the relevant catheters andleadscrew 2080. The delay may allow some portions of the prosthesis tobe uncovered before other portions as the deployment progresses. Itshould also be understood that the prosthetic valve may ultimately berecaptured or obtained for repositioning or removal by simply closingthe sheath catheter 1350 until the leading edge 1725 of said sheathcatheter 1350 again contacts the edge 1720 of the dilator tip 1710.Finally, a distal end 1995 of the guidewire catheter 1830 may be inmated connection with and anchored to the dilator tip 1710.

FIGS. 24A-25 depict an embodiment of a delivery system corresponding tothe description relating to FIGS. 17A-17B. In the same manner as theillustrations depicted in FIGS. 24A-24C, the relationship betweenthumbwheel 1955 rotation and sheath catheter 1350 translation is alsodepicted here. In FIG. 24A, a fully open delivery system 2150 may bedesigned for a flexible connection type of attachment to a prostheticvalve (not shown). An arrow 2190 indicating rotation shows that as thethumbwheel 1955 is rotated, the sheath catheter 1350 may again translate(see arrow 2180 indicating translation) toward the dilator tip 1710. Inthis embodiment, a plurality of flexible connector prongs 2160 may besubjected to a camming action due to their inherent arcuate profile andthe gradually increasing level of contact between said flexibleconnector prongs 2160 and the leading edge 1725 of the sheath catheter1350. This may bring the flexible connector prongs 2160 into closecontact with one another. At the distal tip of each flexible connectorprong 2160 may be a connecting element 2170, which may be asubstantially cylindrical boss that may mate with a substantiallycylindrical hole or cavity within the commissure element of anassociated prosthetic valve (elements 1530, 1555, and 1560 show in FIG.17B). FIGS. 24B and 24C show the logical continuation of the sheathingprocess (2200 partially open, FIG. 24B, and 2210 fully closed, FIG. 24C)whereby the leading edge 1725 of the sheath catheter 1350 may beeventually brought into contact with the edge 1720 of the dilator tip1710.

FIG. 25 shows an exploded view of the delivery system introduced in FIG.24A-24C. The components set forth in this depiction may differ onlyslightly from the components set forth in FIG. 23. The embodiment of adelivery system as shown in FIG. 25 may not require a bell catheter, asthe capturing mechanism may be provided by the relationship between theleading edge 1725 of the sheath catheter 1350 and the plurality offlexible connector prongs 2160. Therefore, the embodiment of FIG. 25 maynot require a bell slider either. In order to operate the device, a usermay only need to draw the sheath catheter 1350 back and forth with thethumbwheel 1955, directly compressing the plurality of flexibleconnector prongs 2160. It should be readily understood that the flexibleconnector prongs 2160 may be fashioned into the distal end of theflexible prong anchoring catheter 2220.

FIGS. 26A-26B depict an embodiment of a delivery system corresponding tothe description relating to FIGS. 18A-18C. FIG. 26A shows an explodedview of an embodiment of a delivery system that may be suitable forconnecting with a prosthetic valve frame having flexible buckle typeanchors. The components set forth in this depiction may differ onlyslightly from the components set forth in FIG. 23. In the embodiment ofFIGS. 26A-26B, the proximal end 2035 of the anchoring catheter 2010 maybe in mated connection with the bell slider 2090 instead of an anchoringnut and may be able to freely translate along with the bell slider 2090when contacted by the leadscrew 2080. The bell slider 2090 may furthercomprise a plurality of pins 2226 that may transmit the force from theleadscrew 2080 to the bell slider 2090 while also providing clearancefor a stationary bell catheter nut 2224 that may anchor and retain thestationary bell catheter 2040 to the delivery system. Thus, by rotatingthe thumbwheel 1955 the leadscrew 2080 may be brought into contact withthe plurality of pins 2226, forcing the bell slider 2090 and anchoringcatheter 2010 proximally away from the dilator tip 1710. This mayeffectively retracts the anchoring catheter 2010 into the stationarybell catheter 2040. This relationship is illustrated in greater detailin FIG. 26B.

In FIG. 26B, an enlarged view 2228 is provided, which shows in detailthe elements that may be present at the distal most end of thetranslating anchoring catheter 2010 and stationary bell catheter 2040.When the distal end 2227 of the anchoring catheter 2010 is brought intothe distal end 2050 of the bell catheter 2040, an aperture 2229 that maybe formed within the distal end 2227 of the anchoring catheter 2010 mayalso brought into said bell catheter distal end 2050. This actioneffectively may provide the mechanism behind the embodiment illustratedin FIGS. 18A-18C.

FIGS. 27 and 28 depict an embodiment of a delivery system correspondingto the description relating to FIGS. 16A-16B. FIG. 27 shows an explodedview 2230 of an embodiment of a delivery system that may suitable forconnecting with a prosthetic valve frame having a single threadedconnector anchor. The components set forth in this depiction may differonly slightly from the components set forth in FIG. 23. The embodimentmay comprise a plurality of stabilizers 1990. The stabilizers mayimprove concentricity of the concentrically nested catheters. Again, aplurality of handle halves (A-side 2250, and B-side 2260) may provide alocation for the various internal components. The delivery system mayalso comprise a plurality of thumbwheels, such as a first thumbwheel1955 for actuating the sheath catheter 1350 and a second thumbwheel 2270for rotating the threaded bell catheter 2040. The first and secondthumbwheels may allow the catheter to connect and disconnect from therelated prosthetic valve. Further, the second thumbwheel 2270 maycontain a hole 2275 through which the proximal end 2060 of the rotatingbell catheter 2040 may be fastened to said second thumbwheel 2270. Anexploded view 2240 of the family of concentrically nested catheters isprovided, and further detail regarding the threaded mechanism at thedistal end of the family of catheters is provided in FIG. 28.

FIG. 28 shows an exploded view 2280 focusing on the distal end of thefamily of nested catheters. Arrow 2300 indicates rotation, whichcorresponds to the rotation of the threaded and distal end of the bellcatheter 2310 in order to connect or disconnect from threaded fastenersthat may be present in a valve prosthesis.

FIGS. 29-31 depict an embodiment of a delivery system corresponding tothe description relating to FIGS. 15A-15B. FIG. 29 shows an explodedview of an embodiment of a delivery system that may be suitable forconnecting with a prosthetic valve frame having a plurality of threadedtype connector anchors (1400, as shown in FIG. 15A). The components setforth in this depiction may be substantially similar to the componentsset forth in FIG. 23. FIG. 29 shows an exploded view of the deliveryhandle portion of the delivery system 2320 and an exploded view of theconcentrically nested catheters 2330. A slot 2390 may be formed at theproximal end of both delivery system handle A-side 2370, and B-side2380. The slots may allow for rotational displacement of a level 2420that may be orthogonal to and originates from a cylindrical torquetransmitting member 2410. The torque transmitting member 2410 may be inmated connection with the proximal or driving end 2355 of a torquecatheter 2350, and may travel concentrically through a catheter mount2400, a leadscrew 2080, a plurality of stabilizers 2360, and a sheathcatheter 1350 before terminating in a distal or driven end 2352 that mayfurther transmit torque through a geared relationship and that isfurther described in FIG. 31. The catheter mount 2400 may provide alateral location and fixation for fixed ends 2345 of a plurality oftwisting thread-connector catheters 2340. The thread-connector catheters2340 may be long, thin, flexible members which may be structurally rigidin compression. The thread-connector catheters may be able to be twistedabout their axes when an appropriate torque is applied. In order tomaintain the adjacency between the torque catheter 2350 and theplurality of thread-connector catheters 2340, a plurality of stabilizers2360 may act as journal bearings to both internally retain the placementof the torque catheter 2350 and to externally retain the placement ofthe plurality of thread-connector catheters 2340. The plurality ofthread-connector catheters may be concentrically nested within thesheath catheter 1350. As previously described, by rotating thethumbwheel 1955 the leadscrew 2080 and by extension sheath catheter 1350may be made to translate, which in turn may cause the leading edge 1725of the sheath catheter 1350 to advance towards or retreat from thedilator tip 1710.

FIG. 30 shows the exploded view 2330 of FIG. 29 in greater detail andshows the nesting configuration of the family of catheters.

FIG. 31 shows an enlarged view 2430, which illustrates in detail themechanical interaction at the distal end of the delivery system of FIG.29. As previously described, actuating the lever (2400, as shown in FIG.29), which may be operably coupled to the driven end 2352 of the torquecatheter (2350, as shown in FIG. 29) may cause the torque catheter torotate, and may further cause a driving gear 2490 to rotate and transmittorque to a plurality of driven gears 2470 that are adjacent to thedistal ends 2342 of the plurality of thread-connector catheters 2340 andby extension also adjacent to the threaded socket 2480 of eachthread-connector catheter 2340. It should be apparent that rotation ofthe driving gear 2490 in a first direction (as shown by arrow 2460indicating rotation) may cause a rotation of each of the driven gears2470 in a second direction, opposite the first (as shown by arrows 2450indicating rotation). A mechanical advantage may exist between thedriving 2490 and driven 2470 gears. The mechanical advantage may resultin an increase in rotational displacement of the driven gears withrespect to the driving gears. The mechanical advantage may provide a 4:1increase in rotational displacement of the driven gears with respect tothe driving gears. At the distal end 2342 of each thread-connectorcatheter 2340 may be a threaded socket (2480, as shown in FIG. 31) whichmay be used to connectedly mate to a threaded fastener that may beanchored to an embodiment of the prosthetic valve (1390 and 1395, asshown in FIG. 15A).

FIG. 32 illustrates a prosthetic valve implanted in a mitral valve of apatient's heart. With traditional methods of implantation andtraditional devices, the natural blood flow path may be disrupted andblood flow may become turbulent. The blood may flow toward the apex ofthe heart and towards the septal wall creating turbulence.

FIG. 33 illustrates the desired blood flow path through the mitral valveand out the ventricle. The native mitral valve directs the blood to flowalong the posterior wall of the ventricle towards the apex of the heartwhere the blood then continues to flow in a non-turbulent manner up theseptal wall and then during heart systole the blood is ejected out ofthe left ventricular outflow tract (LVOT) and through the aorta to therest of the body. In this configuration, the blood flow maintains itsmomentum and conserves its energy resulting in the most efficient flow.

FIG. 34 illustrates a prosthetic valve implanted in a native mitralvalve. The prosthetic mitral valve has features which preferably avoidobstructing the left ventricular outflow tract and also may helpmaintain the natural blood flow path so as to conserve momentum of theblood flow and avoid turbulence. For example, the prosthetic valvepreferably has a large anterior prosthetic valve leaflet 3410 that spansthe width of the native anterior valve leaflet. This will help mimic thesize and motion of the native valve leaflet thereby avoiding obstructionof the LVOT. Additionally, the prosthesis has a low profile so that itdoes not extend too far in to the ventricle, and an atrial flange orskirt helps anchor the prosthesis to the atrial floor. The atrial skirt3420 also preferably has a low profile. The prosthesis may also includeone or preferably two anterior anchoring tabs 3430 that extend behind(anterior of the native leaflet) the native valve leaflets and anchorthe prosthesis to the fibrous trigones on the anterior portion of thevalve, or anchor on tissue adjacent and anterior of the anteriorleaflet. The body 3440 of the valve may direct blood flow to theposterior. Additional details of the anchoring tabs may be found in U.S.Pat. No. 8,579,964, the entire contents of which have been previouslybeen incorporated herein by reference. The body of the prosthesis may bedesigned to avoid LVOT obstruction and this may help direct blood flowdownward along the posterior wall of the heart in a circular mannertoward the apex, and then upward along the septum toward the LVOT,thereby maintaining a substantially normal blood flow path that avoidsturbulance and maintains momentum of the blood flow. Additional detailsabout these and other features of the prosthesis are discussed ingreater detail in this specification.

FIG. 35 illustrates a ventricular view of the prosthesis whichpreferably has a large anterior prosthetic leaflet, and two posteriorleaflets. Preferably, three commissure posts are used to support theprosthetic valve leaflets and form a tricuspid prosthetic valve. Theprosthesis may comprise an atrial skirt 3520. Additionally, theprosthesis preferably includes two anterior anchor tabs 3510 andoptionally one or more posterior anchor tabs 3530. The anterior anchortabs may anchor to the fibrous trigones of the valve or they may anchorto tissue that is anterior of the anterior leaflet and adjacent thereto,and in order to avoid interfering with movement of the anteriorprosthetic leaflet, the anterior anchor tabs are also preferably at thesame circumferential position as the commissure posts. In this exemplaryembodiment, the anterior anchor tabs are located approximately at the 10o'clock and 2 o'clock positions along with two of the commissure posts.The prosthesis is preferably D-shaped in order to conform to the nativevalve anatomy. Therefore, the anterior portion of the valve ispreferably flat and linear so that it does not impinge on the LVOT, andthe posterior of the prosthesis is preferably cylindrical so that itconforms to the native valve. In some embodiments, instead of a flat andlinear anterior portion, the anterior portion may be concave or slightlyconvex.

FIG. 36A illustrates more clearly the two anterior anchor tabs whichextend upward toward the atrium and away from the commissure posts whichextend toward the ventricle, and similarly the posterior anchor alsoextends upward toward the atrium while the adjacent commissure postextends downward toward the ventricle. Note that in this view, only oneof the anterior anchor tabs is visible. The prosthesis may comprise anatrial skirt 3610.

FIG. 36B illustrates an outflow view of the prosthesis of FIG. 36A,whereby both anterior trigonal anchoring tabs are present, as well asthe posterior anchoring tab, and the commissures associated with each ofsaid tabs. It should be apparent that the commissure posts and anchoringtabs are adjacent each other. The prosthesis may comprise an anterioranchor 3620, an anterior leaflet 3630, an anterior commissure 3640, aposterior anchor 3650, and a posterior commissure 3660.

FIG. 37 illustrates two embodiments of structure on the prosthesis forcoupling it to a delivery catheter. The figure shows a pattern of theanchor frame after it has been flattened and unrolled. It is formed fromnumerous interconnected struts which form open or closed cells that canself-expand or that may be balloon expandable. On the left side of FIG.37, a first exemplary embodiment shows a single arcuate strut that formsa closed single cell on the atrial portion of the device. This strut maybe folded radially outward to form a flanged region or atrial skirtwhich can anchor to the atrial floor. A commissure post with a D-shapedor mushroom head shaped, or anchor shaped portion on the opposite end ofthe prosthesis may be used to couple and uncouple the device from adelivery catheter as described previously in this specification and inU.S. Pat. No. 8,579,964 previously incorporated by reference, and isgenerally on a ventricular portion of the device. A triangular anchortab is nested in the single cell between the commissure post and theatrial flange. Thus, the anchor tab is superior to the commissure post.The anchor tab may be formed to flare radially outward during deploymentso that the anchor tab may be disposed behind a native leaflet (anteriorto the anterior native leaflet, or posterior to a native posteriorleaflet) and engage the anterior or posterior native anatomy asdescribed in this specification. The commissure may have suture holesdisposed therein in order to allow sutures to attach tissue or othermaterial to the commissure posts. Nesting of the anchor tab adjacent thecommissure post helps reduce overall device profile.

The right-hand side of FIG. 37 illustrates another exemplary embodimentof an anchor structure that allows the prosthesis to be coupled to thedelivery catheter. On the right-hand side, multiple closed cells formthe atrial region of the device which may be formed to flare radiallyoutward and create a flanged region that may be secured to the atrialfloor of the atrium. Two commissure posts include a slotted region forreceiving sutures so that tissue or other material may be coupled to thedevice. The commissure posts are connected together with a wishboneshaped strut having a central tab that may be coupled to the deliverycatheter. The wishbone may extend between two commissures or threecommissures, or more commissures. Thus, in this embodiment, only asingle connector is used to couple the prosthesis to the deliverycatheter. The struts of the frame may be EDM machined or laser cut fromtubing (e.g. hypo tube), laser cutting or photo etching a flat sheet andwelding the ends together, or by other techniques known in the art.

FIG. 38 illustrates a perspective view of the prosthetic mitral valve.An upper portion includes an atrial skirt or atrial flange thatgenerally takes the same form as the atrial skirt or flange described inU.S. Pat. No. 8,579,964, previously incorporated herein by reference.The prosthetic valve leaflets are also shown, and preferably include onelarge anterior leaflet that spans the width of the native anteriormitral valve leaflet, and may include two, or three, or more posteriorprosthetic leaflets. Thus, the prosthetic valve may only have twoprosthetic leaflets, or three or more prosthetic leaflets in total. Twoanterior anchoring tabs also preferably share the same position as thecommissure posts. This keeps the anterior commissure posts and theanterior anchor tabs out of the flow path thereby helping to avoid LVOTobstruction, and also helps keep overall profile of the device to aminimum in the collapsed configuration which is desirable duringdelivery.

FIG. 39A shows an anterior view of the prosthetic valve in the expandedconfiguration with the anchoring tabs flared outward and in the expandedconfiguration.

FIG. 39B shows a top view of the prosthetic valve with four prostheticleaflets including one large anterior leaflet that spans the width ofthe native anterior leaflet and three posterior leaflets, all coupledtogether with four commissure posts that may optionally be combined withfour anchor tabs. Two of these anchor tabs are preferably anterioranchoring tabs for anchoring the prosthetic valve to the fibroustrigones or any other anatomic location described herein including aregion anterior of the anterior leaflet and adjacent thereto, and thetwo posterior tabs may anchor the prosthetic valve to the posteriorshelf of the posterior annulus and posterior to the native posteriorleaflet.

FIG. 40 shows deployment of the prosthesis by either a transseptal or bya transapical delivery system. In either, preferably an outer sheathcatheter constrains the device from self-expanding and when the outersheath catheter is retracted the device self-expands. Here, the sheathcatheter is partially retracted and the anterior 4010 and posterior 4020anchor tabs are partially deployed.

FIG. 41 shows a partial perspective view of the prosthetic valve with anupper saddle shaped atrial skirt for atrial anchoring along with thecombined large anterior leaflet and two or three posterior leaflets andcombined anchor tabs/commissure posts.

FIG. 42 shows a flat pattern of the combined anterior or posterioranchor tab that is nested in the commissure post. The anchors inalternative embodiments may be cut above the commissure posts and bentbackward during heat treating and shape setting so they can anchor tothe native heart valve anatomy as described in this specification. Thismay require the anchors to be deployed first, before other portions ofthe prosthesis, as seen in FIG. 40. This may also involve anchoring ofthe prosthesis to the delivery catheter on both the inflow end and theoutflow ends of the prosthesis for successful delivery.

FIG. 43A shows the unexpanded anchor tabs which may be triangular in thecollapsed configuration and have a horizontal paddle shape in theexpanded configuration in order to increase the contact area and therebyminimize tissue trauma, tissue piercing during anchoring, as illustratedin FIG. 43B. Alternatively, the anchors may have pointed tips whichpierce or embed in tissue to help anchor the device.

FIG. 43C shows an exemplary cut pattern of the prosthesis that providesthe results seen in FIGS. 43A-43B.

FIG. 44 illustrates a top view of the prosthetic valve with a largeanterior leaflet that spans the width of the native anterior leaflet,and two posterior prosthetic leaflets. The prosthetic leaflets arecoupled together with three commissure posts.

FIG. 45 shows portions of the prosthesis including the upper atrialskirt, an annular region and the anchor tabs which may be combined withcommissure posts. The anchor tabs are preferably 10 mm-50 mm long, morepreferably 20 mm-30 mm long to allow adequate length to go under andbehind the native valve leaflets to reach the fibrous trigones and/orposterior annulus or to anchor on other anatomic locations describedherein including regions that are anterior of the native leaflet andadjacent thereto. Optionally, the prosthetic valve may not include aposterior anchoring tab. The annular section which is preferablyD-shaped may be radially expanded into engagement with the native valveannulus and thus the radial force may be adequate to prevent theposterior portion of the prosthesis from tilting or otherwise pivotingupward into the atrium. Or teeth may be used to engage and/or penetratethe posterior annulus.

In any embodiment, the prosthesis may be recaptured and resheathed ifneeded in order to either abort the delivery procedure or to repositionthe device.

Preferred embodiments are formed from nitinol or any other biocompatiblematerial that is self-expanding. Preferred target sizes and profiles maybe dependent on patient anatomy, but are estimated to be approximately30 mm-50 mm×40 mm-50 mm D-shaped prosthesis that may be delivered in adelivery system that is less than 45 French in size. More preferably,the prosthesis is 35 mm-45 mm×40 mm-50 mm D-shaped and delivered with adelivery system less than 40 French in size. Smaller sizes arepreferred, and nominally, the prosthesis is 40 mm×45 mm D-shaped anddelivered with a delivery system less than 40 French.

In some embodiments, tethers may be used to help couple the prosthesisto the delivery system for controlling delivery.

FIG. 46 shows a top view of a prosthetic valve with four prostheticleaflets and four commissure posts. Optionally, four anchoring tabs mayalso be co-located with the four commissure posts.

FIG. 47 shows a top view of prosthetic valve with three prostheticleaflets and three commissure posts. Optionally, three anchoring tabsmay also be co-located with the three commissure posts.

FIG. 48 shows the prosthesis unrolled and flattened out and having threecommissure posts with three prosthetic leaflets and three anchoringtabs. The atrial skirt is also illustrated below the commissure postsand anchor tabs.

FIG. 49 shows the native anterior and posterior leaflet unrolled andflattened and superimposed over the three anchoring tabs.

FIG. 50 shows an embodiment where the anchor tabs (triangular shapedcells) are connected to the commissure posts configured for deploymentas depicted in FIG. 40, where the anchor tabs are deployed first as anouter sheath when the delivery system is retracted. Alternative catheterattachment methods are depicted for this embodiment. Either the use ofmushroom shaped anchor tabs at the atrial aspect of the device or acentral wishbone style attachment can be used to secure the device tothe catheter.

FIG. 51 shows a large anterior leaflet superimposed over two anterioranchor tabs and a posterior section of diamond shaped cells which mayengage or pierce the posterior annulus in an exemplary embodiment thatdoes not use a posterior anchor tab.

FIG. 52 illustrates another exemplary embodiment showing two anterioranchoring tabs formed and nested within the anterior commissure postsand a series of expandable diamond shaped cells which may anchor againstthe posterior annulus or may pierce into the posterior annulus therebyavoiding the need for a posterior anchoring tab. This embodimentincludes four commissure posts.

FIG. 53 illustrates another exemplary flat pattern of a prosthetic valvehaving two anterior anchor tabs nested in two anterior commissure postsand two posterior commissure posts. The atrial flange is shown below thecommissure posts.

FIG. 54 shows a perspective view of a prosthetic valve with fourcommissure posts and a large anterior prosthetic leaflet coupled to twoanterior commissure posts.

FIG. 55 shows a native mitral valve adjacent the aortic valve andpreferably the anterior leaflet moves well away from the LVOT duringsystole. Preferably a prosthetic anterior leaflet would have similarmotion to maintain natural flow dynamics such as maintaining blood flowmomentum and reducing or eliminating turbulance.

FIG. 56 shows another exemplary embodiment of a section of prostheticvalve having an anchoring tab nested within the commissure post and theadjacent closed cells of the frame are also shown.

FIG. 57 illustrates still another exemplary embodiment of a prostheticvalve having a commissure post and an anchoring tab nested with thecommissure post.

FIG. 58 shows yet another variation of a prosthetic valve having ananchoring tab nested within the commissure post.

FIG. 59 shows how variable strut thickness (e.g. thicker 5910 andthinner 5920 regions) may be used to control the material properties ofthe prosthesis to create stiffer regions and less stiff regions.

While preferred embodiments of the present invention have beenillustrated and described herein, it will be obvious to those skilled inthe art that such embodiments are provided by way of example only.Numerous variations, changes, and substitutions will now occur to thoseskilled in the art without departing from the invention. It should beunderstood that various alternatives to the embodiments of the inventiondescribed herein may be employed in practicing the invention. It isintended that the following claims define the scope of the invention andthat methods and structures within the scope of these claims and theirequivalents be covered thereby.

What is claimed is:
 1. A prosthetic heart valve for implantation in anative heart valve of a patient, said prosthetic heart valve comprising:a radially expandable frame having an expanded configuration, acollapsed configuration, an upstream end, and a downstream end; acommissure post having a free end and an opposite end coupled to theframe; an anterior anchoring tab coupled to an anterior portion of theexpandable frame adjacent the downstream end, wherein the anchoring tabextends radially outward from the expandable frame and the anchoring tabis configured to anchor the expandable frame to an anterior portion ofthe native heart valve, and wherein the anchoring tab is nested withinthe commissure post when the expandable frame is in the collapsedconfiguration; and a plurality of prosthetic valve leaflets each havinga free end and a fixed end, wherein the fixed end is coupled to theexpandable frame, and wherein the commissure post is coupled to at leastone of the prosthetic valve leaflets.
 2. The prosthetic valve of claim1, wherein the free ends of the plurality of prosthetic valve leafletshave an open configuration and a closed configuration, wherein in theopen configuration the free ends are disposed away from one another toallow antegrade flow therepast, and in the closed configuration the freeends are disposed adjacent one another to substantially preventretrograde flow therepast.
 3. The prosthetic valve of claim 1, whereinthe plurality of prosthetic valve leaflets comprise an anteriorprosthetic leaflet sized to span a width of a native anterior valveleaflet from a first fibrous trigone to a second fibrous trigone, andwherein in systole the anterior prosthetic leaflet is configured todeflect away from a left ventricular outflow tract (LVOT) of the nativeheart to provide a clear unobstructed outflow path.
 4. The prostheticvalve of claim 1, further comprising a second anterior anchoring tabcoupled to an anterior portion of the expandable frame adjacent thedownstream end, and wherein second anchoring tab extends radiallyoutward from the expandable frame in the expanded configuration, and thesecond anchoring tab is configured to anchor the frame to a secondanterior portion of the native heart valve.
 5. The prosthetic valve ofclaim 1, wherein the expandable frame comprises a D-shaped cross-sectionin the expanded configuration, wherein the anterior portion of theexpandable frame is substantially flat to prevent impingement of theanterior portion against the left ventricular outflow tract (LVOT), anda posterior portion of the expandable frame is partially cylindricallyshaped to conform with a posterior portion of the native valve.
 6. Theprosthetic valve of claim 1, wherein the native valve is a native mitralvalve.
 7. The prosthetic valve of claim 1, wherein the anterioranchoring tab comprises a fixed end and a free end, and wherein thefixed end originates from a downstream portion of the commissure post.8. The prosthetic valve of claim 1, wherein the anterior anchoring taboriginates from a circumferential position on a circumference of theexpandable frame, and wherein the commissure post originates from thecircumferential position.
 9. The prosthetic valve of claim 1, whereinthe commissure post comprises an anchoring element adjacent the free endthereof, the anchoring element configured to engage a delivery system.10. A method of anchoring a prosthesis to a native heart valve, saidmethod comprising: providing a prosthetic heart valve comprising anexpandable anchor frame, the anchor frame having an upstream end and adownstream end, one or more commissure posts each having a free end anda fixed end coupled to the anchor frame, a plurality of prosthetic valveleaflets coupled to the anchor frame, and an anterior anchoring tabcoupled to the anchor frame; radially expanding the anchor frame from acollapsed configuration to an expanded configuration to engage thenative heart valve; radially expanding the anterior anchoring taboutward from the anchor frame; radially expanding the anterior anchoringtab away from a nested configuration wherein the anterior anchoring tabis nested within the commissure post in the collapsed configuration; andanchoring the prosthesis to the native heart valve by engaging theanterior anchoring tab against an anterior portion of the native heartvalve.
 11. The method of claim 10, wherein the prosthetic heart valve isa prosthetic mitral valve.
 12. The method of claim 10, wherein theprosthetic valve comprises an anterior leaflet, the method furthercomprising spanning a width of a native anterior valve leaflet betweentwo native fibrous trigones with the anterior leaflet.
 13. The method ofclaim 12, further comprising causing deflection of the anterior leafletaway from the left ventricular outflow tract (LVOT) thereby forming anunobstructed outflow path during systole.
 14. The method of claim 10,further comprising a second anterior anchor tab coupled to the anchorframe, the method further comprising radially expanding the secondanterior anchor tab from a collapsed configuration to an expandedconfiguration to engage the native heart valve.
 15. The method of claim14, further comprising radially expanding the second anterior anchoringtab away from a nested configuration wherein the second anterioranchoring tab is nested within a second commissure post in the collapsedconfiguration, and wherein the second commissure post is coupled to theanchor frame.
 16. The method of claim 10, further comprising a posterioranchoring tab coupled to the anchor frame, the method further comprisingradially expanding the posterior anchoring tab from a collapsedconfiguration to an expanded configuration to engage the native heartvalve.
 17. The method of claim 16, further comprising radially expandingthe posterior anchor tab away from a nested configuration wherein theposterior anchoring tab is nested within a third commissure post in thecollapsed configuration, and wherein the third commissure post iscoupled to the anchor frame.